Trial Outcomes & Findings for Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults (NCT NCT00492557)
NCT ID: NCT00492557
Last Updated: 2012-02-17
Results Overview
Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1185 participants
Primary outcome timeframe
Baseline and 1 month after TIV vaccination
Results posted on
2012-02-17
Participant Flow
A total of 1185 participants were enrolled, of which 1160 were randomized.
Participant milestones
| Measure |
13vPnC+TIV Followed by Placebo 1 Month Later
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
|
Placebo+TIV Followed by 13vPnC 1 Month Later
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
|
|---|---|---|
|
Overall Study
STARTED
|
580
|
580
|
|
Overall Study
Vaccinated Dose 1
|
577
|
575
|
|
Overall Study
Vaccinated Dose 2
|
560
|
558
|
|
Overall Study
COMPLETED
|
556
|
557
|
|
Overall Study
NOT COMPLETED
|
24
|
23
|
Reasons for withdrawal
| Measure |
13vPnC+TIV Followed by Placebo 1 Month Later
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
|
Placebo+TIV Followed by 13vPnC 1 Month Later
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
|
|---|---|---|
|
Overall Study
Subject request
|
12
|
11
|
|
Overall Study
Protocol Violation
|
7
|
8
|
|
Overall Study
Other
|
2
|
2
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Failed to return
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
Baseline characteristics by cohort
| Measure |
13vPnC+TIV Followed by Placebo 1 Month Later
n=576 Participants
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
|
Placebo+TIV Followed by 13vPnC 1 Month Later
n=575 Participants
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
|
Total
n=1151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
287 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
572 Participants
n=5 Participants
|
|
Age Continuous
|
72.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
72.1 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
579 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 month after TIV vaccinationPopulation: Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.
Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.
Outcome measures
| Measure |
13vPnC+TIV
n=549 Participants
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
|
Placebo+TIV
n=547 Participants
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
|
|---|---|---|
|
TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
Influenza virus subtype: A/H1N1
|
80.3 Percentage of participants
Interval 76.7 to 83.5
|
78.6 Percentage of participants
Interval 74.9 to 81.9
|
|
TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
Influenza virus subtype: A/H3N2
|
58.0 Percentage of participants
Interval 53.7 to 62.2
|
62.6 Percentage of participants
Interval 58.4 to 66.6
|
|
TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
Influenza virus subtype: B
|
52.2 Percentage of participants
Interval 47.9 to 56.4
|
54.0 Percentage of participants
Interval 49.7 to 58.3
|
PRIMARY outcome
Timeframe: 1 month after 13vPnC vaccinationPopulation: Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.
IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Outcome measures
| Measure |
13vPnC+TIV
n=549 Participants
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
|
Placebo+TIV
n=547 Participants
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
|
|---|---|---|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 1
|
2.52 mcg/mL
Interval 2.07 to 3.06
|
3.20 mcg/mL
Interval 2.61 to 3.91
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 3
|
1.08 mcg/mL
Interval 0.94 to 1.24
|
1.15 mcg/mL
Interval 1.01 to 1.3
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 4
|
2.15 mcg/mL
Interval 1.79 to 2.6
|
3.24 mcg/mL
Interval 2.65 to 3.96
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 5
|
4.74 mcg/mL
Interval 4.08 to 5.5
|
6.90 mcg/mL
Interval 5.87 to 8.11
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 6A
|
4.61 mcg/mL
Interval 4.0 to 5.31
|
6.10 mcg/mL
Interval 5.13 to 7.24
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 6B
|
6.24 mcg/mL
Interval 5.27 to 7.39
|
6.43 mcg/mL
Interval 5.33 to 7.76
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 7F
|
7.63 mcg/mL
Interval 6.5 to 8.96
|
9.04 mcg/mL
Interval 7.58 to 10.79
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 9V
|
4.97 mcg/mL
Interval 4.19 to 5.91
|
6.21 mcg/mL
Interval 5.27 to 7.33
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 14
|
8.95 mcg/mL
Interval 7.33 to 10.95
|
12.44 mcg/mL
Interval 9.94 to 15.57
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 18C
|
8.88 mcg/mL
Interval 7.55 to 10.45
|
11.07 mcg/mL
Interval 9.4 to 13.04
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 19A
|
11.93 mcg/mL
Interval 10.23 to 13.92
|
17.10 mcg/mL
Interval 14.54 to 20.1
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 19F
|
4.78 mcg/mL
Interval 4.0 to 5.71
|
7.39 mcg/mL
Interval 6.02 to 9.08
|
|
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Serotype 23F
|
5.82 mcg/mL
Interval 4.74 to 7.14
|
6.11 mcg/mL
Interval 4.97 to 7.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1 through 14 after 13vPnC vaccinationPopulation: Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.
Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (\> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).
Outcome measures
| Measure |
13vPnC+TIV
n=577 Participants
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
|
Placebo+TIV
n=558 Participants
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
|
|---|---|---|
|
Percentage of Participants With Pre-specified Local Reactions
Redness: Any (n= 440, 432)
|
16.6 percentage of participants
Interval -0.4 to 9.0
|
12.3 percentage of participants
Interval -0.4 to 9.0
|
|
Percentage of Participants With Pre-specified Local Reactions
Redness: Mild (n= 438, 432)
|
14.4 percentage of participants
Interval 0.3 to 9.1
|
9.7 percentage of participants
Interval 0.3 to 9.1
|
|
Percentage of Participants With Pre-specified Local Reactions
Redness: Moderate (n= 433, 424)
|
6.0 percentage of participants
Interval -3.4 to 3.1
|
6.1 percentage of participants
Interval -3.4 to 3.1
|
|
Percentage of Participants With Pre-specified Local Reactions
Redness: Severe (n= 429, 420)
|
0.7 percentage of participants
Interval -1.8 to 1.2
|
1.0 percentage of participants
Interval -1.8 to 1.2
|
|
Percentage of Participants With Pre-specified Local Reactions
Swelling: Any (n= 441, 431)
|
13.8 percentage of participants
Interval -0.7 to 8.0
|
10.2 percentage of participants
Interval -0.7 to 8.0
|
|
Percentage of Participants With Pre-specified Local Reactions
Swelling: Mild (n= 440, 430)
|
11.8 percentage of participants
Interval -0.3 to 7.7
|
8.1 percentage of participants
Interval -0.3 to 7.7
|
|
Percentage of Participants With Pre-specified Local Reactions
Swelling: Moderate (n= 432, 423)
|
4.2 percentage of participants
Interval -3.7 to 2.1
|
5.0 percentage of participants
Interval -3.7 to 2.1
|
|
Percentage of Participants With Pre-specified Local Reactions
Swelling: Severe (n= 428, 420)
|
0.2 percentage of participants
Interval -0.7 to 1.3
|
0.0 percentage of participants
Interval -0.7 to 1.3
|
|
Percentage of Participants With Pre-specified Local Reactions
Pain: Any (n= 480, 470)
|
40.0 percentage of participants
Interval -9.7 to 3.0
|
43.4 percentage of participants
Interval -9.7 to 3.0
|
|
Percentage of Participants With Pre-specified Local Reactions
Pain: Mild (n= 470, 462)
|
34.3 percentage of participants
Interval -9.8 to 2.6
|
37.9 percentage of participants
Interval -9.8 to 2.6
|
|
Percentage of Participants With Pre-specified Local Reactions
Pain: Moderate (n= 447, 442)
|
14.8 percentage of participants
Interval -9.9 to 0.1
|
19.7 percentage of participants
Interval -9.9 to 0.1
|
|
Percentage of Participants With Pre-specified Local Reactions
Pain: Severe (n= 429, 421)
|
1.4 percentage of participants
Interval -3.4 to 0.8
|
2.6 percentage of participants
Interval -3.4 to 0.8
|
|
Percentage of Participants With Pre-specified Local Reactions
Limitation of arm movement: Any (n= 445, 432)
|
13.9 percentage of participants
Interval -5.6 to 3.8
|
14.8 percentage of participants
Interval -5.6 to 3.8
|
|
Percentage of Participants With Pre-specified Local Reactions
Limitation of arm movement: Mild (n= 444, 432)
|
13.1 percentage of participants
Interval -4.9 to 4.2
|
13.4 percentage of participants
Interval -4.9 to 4.2
|
|
Percentage of Participants With Pre-specified Local Reactions
Limitation of arm movement:Moderate (n= 430, 420)
|
1.4 percentage of participants
Interval -1.2 to 2.2
|
1.0 percentage of participants
Interval -1.2 to 2.2
|
|
Percentage of Participants With Pre-specified Local Reactions
Limitation of arm movement: Severe (n= 429, 420)
|
1.9 percentage of participants
Interval -1.4 to 2.4
|
1.4 percentage of participants
Interval -1.4 to 2.4
|
|
Percentage of Participants With Pre-specified Local Reactions
Any local reaction (n= 488, 470)
|
46.9 percentage of participants
Interval -6.0 to 6.7
|
46.6 percentage of participants
Interval -6.0 to 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1 through 14 after 13vPnC vaccinationPopulation: Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.
Systemic events (Any fever \>= 38 degrees Celsius \[C\]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.
Outcome measures
| Measure |
13vPnC+TIV
n=577 Participants
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
|
Placebo+TIV
n=558 Participants
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
|
|---|---|---|
|
Percentage of Participants With Pre-specified Systemic Events
Fever >=38 degreesC but <38.5 degreesC (n=434,423)
|
3.0 Percentage of participants
Interval -2.5 to 2.3
|
3.1 Percentage of participants
Interval -2.5 to 2.3
|
|
Percentage of Participants With Pre-specified Systemic Events
Fever >=38.5 degreesC but <39 degreesC (n=430,421)
|
1.4 Percentage of participants
Interval -1.2 to 2.2
|
1.0 Percentage of participants
Interval -1.2 to 2.2
|
|
Percentage of Participants With Pre-specified Systemic Events
Fever >=39degreesC but <=40.0degreesC (n=428,420)
|
0.0 Percentage of participants
Interval -0.9 to 0.9
|
0.0 Percentage of participants
Interval -0.9 to 0.9
|
|
Percentage of Participants With Pre-specified Systemic Events
Fever >40.0 degrees C (n= 429, 422)
|
1.4 Percentage of participants
Interval -0.8 to 2.4
|
0.7 Percentage of participants
Interval -0.8 to 2.4
|
|
Percentage of Participants With Pre-specified Systemic Events
Fatigue (n= 476, 456)
|
37.4 Percentage of participants
Interval 2.8 to 14.9
|
28.5 Percentage of participants
Interval 2.8 to 14.9
|
|
Percentage of Participants With Pre-specified Systemic Events
Headache (n= 472, 449)
|
32.6 Percentage of participants
Interval 2.1 to 13.8
|
24.7 Percentage of participants
Interval 2.1 to 13.8
|
|
Percentage of Participants With Pre-specified Systemic Events
Chills (n= 443, 429)
|
13.8 Percentage of participants
Interval 0.4 to 9.0
|
9.1 Percentage of participants
Interval 0.4 to 9.0
|
|
Percentage of Participants With Pre-specified Systemic Events
Rash (n= 433, 427)
|
6.9 Percentage of participants
Interval -3.3 to 3.6
|
6.8 Percentage of participants
Interval -3.3 to 3.6
|
|
Percentage of Participants With Pre-specified Systemic Events
Vomiting (n= 432, 424)
|
3.0 Percentage of participants
Interval -0.7 to 3.6
|
1.7 Percentage of participants
Interval -0.7 to 3.6
|
|
Percentage of Participants With Pre-specified Systemic Events
Decreased appetite (n= 450, 434)
|
16.9 Percentage of participants
Interval 1.0 to 10.2
|
11.3 Percentage of participants
Interval 1.0 to 10.2
|
|
Percentage of Participants With Pre-specified Systemic Events
New muscle pain (n= 468, 448)
|
26.9 Percentage of participants
Interval -2.2 to 9.1
|
23.4 Percentage of participants
Interval -2.2 to 9.1
|
|
Percentage of Participants With Pre-specified Systemic Events
Any aggravated muscle pain (n= 454, 439)
|
18.7 Percentage of participants
Interval -1.2 to 8.7
|
15.0 Percentage of participants
Interval -1.2 to 8.7
|
|
Percentage of Participants With Pre-specified Systemic Events
New joint pain (n= 452, 435)
|
16.2 Percentage of participants
Interval 0.1 to 9.2
|
11.5 Percentage of participants
Interval 0.1 to 9.2
|
|
Percentage of Participants With Pre-specified Systemic Events
Any aggravated joint pain (n= 452, 428)
|
15.7 Percentage of participants
Interval 2.7 to 11.4
|
8.6 Percentage of participants
Interval 2.7 to 11.4
|
|
Percentage of Participants With Pre-specified Systemic Events
Any systemic event (n= 510, 488)
|
60.2 Percentage of participants
Interval 5.4 to 17.8
|
48.6 Percentage of participants
Interval 5.4 to 17.8
|
POST_HOC outcome
Timeframe: 1 month after 13vPnC vaccinationPopulation: Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. n= number of participants with a determinate OPA antibody titer to the given serotype.
Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of a subset of participants using a microcolony OPA (mcOPA) assay.
Outcome measures
| Measure |
13vPnC+TIV
n=259 Participants
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
|
Placebo+TIV
n=255 Participants
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
|
|---|---|---|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 1 (n= 256, 255)
|
88 Geometric mean titers
Interval 71.1 to 108.3
|
95 Geometric mean titers
Interval 76.8 to 117.9
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 3 (n= 235, 237)
|
46 Geometric mean titers
Interval 37.9 to 56.1
|
51 Geometric mean titers
Interval 41.7 to 61.7
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 4 (n= 247, 245)
|
997 Geometric mean titers
Interval 766.3 to 1296.0
|
1486 Geometric mean titers
Interval 1174.7 to 1879.8
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 5 (n= 245, 234)
|
124 Geometric mean titers
Interval 97.3 to 158.8
|
112 Geometric mean titers
Interval 85.1 to 146.3
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 6A (n= 250, 252)
|
1220 Geometric mean titers
Interval 950.6 to 1566.7
|
1597 Geometric mean titers
Interval 1256.4 to 2030.3
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 6B (n= 259, 248)
|
1564 Geometric mean titers
Interval 1239.4 to 1973.9
|
2017 Geometric mean titers
Interval 1564.8 to 2599.9
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 7F (n= 246, 248)
|
607 Geometric mean titers
Interval 444.2 to 828.8
|
835 Geometric mean titers
Interval 619.9 to 1123.9
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 9V (n= 247, 242)
|
477 Geometric mean titers
Interval 348.5 to 652.7
|
723 Geometric mean titers
Interval 528.1 to 988.9
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 14 (n= 247, 236)
|
975 Geometric mean titers
Interval 781.6 to 1215.5
|
1088 Geometric mean titers
Interval 858.4 to 1379.1
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 18C (n= 250, 244)
|
1158 Geometric mean titers
Interval 909.5 to 1475.1
|
1415 Geometric mean titers
Interval 1122.0 to 1785.8
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 19A (n= 251, 247)
|
445 Geometric mean titers
Interval 365.1 to 542.1
|
539 Geometric mean titers
Interval 427.8 to 679.7
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 19F (n= 247, 242)
|
378 Geometric mean titers
Interval 295.8 to 483.8
|
467 Geometric mean titers
Interval 360.7 to 605.1
|
|
13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Serotype 23F (n= 252, 242)
|
245 Geometric mean titers
Interval 180.2 to 332.4
|
295 Geometric mean titers
Interval 217.9 to 400.8
|
Adverse Events
13vPnC+TIV
Serious events: 4 serious events
Other events: 307 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 194 other events
Deaths: 0 deaths
Placebo+TIV
Serious events: 0 serious events
Other events: 256 other events
Deaths: 0 deaths
13vPnC
Serious events: 5 serious events
Other events: 237 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC+TIV
n=576 participants at risk
Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.
|
Placebo
n=559 participants at risk
Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM \[13vPnC + TIV\]).
|
Placebo+TIV
n=575 participants at risk
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
|
13vPnC
n=558 participants at risk
Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM \[Placebo + TIV\]).
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Cardiac failure
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Investigations
Endoscopy small intestine
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
Other adverse events
| Measure |
13vPnC+TIV
n=576 participants at risk
Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.
|
Placebo
n=559 participants at risk
Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM \[13vPnC + TIV\]).
|
Placebo+TIV
n=575 participants at risk
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
|
13vPnC
n=558 participants at risk
Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM \[Placebo + TIV\]).
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (any)
|
16.6%
73/440 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.5%
6/393 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.5%
11/433 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
12.3%
53/432 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (mild)
|
14.4%
63/438 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.5%
6/393 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.4%
6/433 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
9.7%
42/432 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (moderate)
|
6.0%
26/433 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/392 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.2%
5/431 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
6.1%
26/424 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (severe)
|
0.70%
3/429 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/392 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/431 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.95%
4/420 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (any)
|
13.8%
61/441 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.0%
4/394 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.8%
12/435 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
10.2%
44/431 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (mild)
|
11.8%
52/440 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.0%
4/394 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.1%
9/434 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
8.1%
35/430 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (moderate)
|
4.2%
18/432 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.25%
1/393 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.2%
5/433 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
5.0%
21/423 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (severe)
|
0.23%
1/428 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/392 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.23%
1/431 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/420 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (any)
|
40.0%
192/480 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
9.7%
40/411 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
10.1%
45/445 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
43.4%
204/470 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (mild)
|
34.3%
161/470 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
8.1%
33/408 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
9.0%
40/443 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
37.9%
175/462 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (moderate)
|
14.8%
66/447 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.5%
10/397 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
3.2%
14/437 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
19.7%
87/442 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (severe)
|
1.4%
6/429 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/392 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/431 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.6%
11/421 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (any)
|
13.9%
62/445 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
5.0%
20/397 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
5.9%
26/440 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
14.8%
64/432 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (mild)
|
13.1%
58/444 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
4.3%
17/397 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
5.9%
26/440 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
13.4%
58/432 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (moderate)
|
1.4%
6/430 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.0%
4/393 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.23%
1/432 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.95%
4/420 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (severe)
|
1.9%
8/429 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.0%
4/392 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/431 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.4%
6/420 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Fever ≥ 38 degrees C but < 38.5 degrees C
|
3.0%
13/434 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.0%
8/398 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.8%
8/434 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
3.1%
13/423 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Fever ≥ 38.5 degrees C but < 39 degrees C
|
1.4%
6/430 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.0%
4/394 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.2%
5/433 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.95%
4/421 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Fever ≥ 39 degrees C but ≤ 40.0 degrees C
|
0.00%
0/428 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.76%
3/394 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.23%
1/431 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/420 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Fever > 40.0 degrees C
|
1.4%
6/429 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.0%
4/393 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.3%
10/438 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.71%
3/422 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Fatigue
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Headache
|
32.6%
154/472 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
26.1%
114/436 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
29.7%
139/468 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
24.7%
111/449 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Chills
|
13.8%
61/443 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
7.9%
32/404 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
9.1%
40/440 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
9.1%
39/429 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Rash
|
6.9%
30/433 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
2.5%
10/397 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
3.4%
15/436 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
6.8%
29/427 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Vomiting
|
3.0%
13/432 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
3.0%
12/398 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
3.4%
15/437 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.7%
7/424 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Decreased appetite
|
16.9%
76/450 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
14.0%
58/415 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
14.6%
66/452 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
11.3%
49/434 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
New muscle pain
|
26.9%
126/468 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
11.4%
47/413 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
16.7%
76/456 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
23.4%
105/448 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Any aggravated muscle pain
|
18.7%
85/454 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
10.7%
44/410 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
14.0%
63/449 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
15.0%
66/439 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
New joint pain
|
16.2%
73/452 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
11.0%
45/408 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
13.1%
59/451 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
11.5%
50/435 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Any aggravated joint pain
|
15.7%
71/452 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
11.1%
45/407 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
13.0%
58/447 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
8.6%
37/428 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Cardiac failure
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Eye disorders
Glaucoma
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Eye disorders
Cataract
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Eye disorders
Conjunctivitis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Colitis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Nausea
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site haematoma
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site pain
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site erythema
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site pruritus
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site swelling
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Malaise
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Oedema peripheral
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Sensation of foreign body
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Pyrexia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
General disorders
Influenza like illness
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
6/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.72%
4/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.4%
8/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.6%
9/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
7/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.8%
10/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.0%
6/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
1.4%
8/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Localised infection
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.35%
2/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Cystitis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.90%
5/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pharyngitis
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.35%
2/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.72%
4/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Enterovirus infection
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Influenza
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Otitis externa
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Tracheobronchitis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Viral infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Otitis media
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Investigations
Total lung capacity decreased
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Investigations
Cardiac murmur
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Investigations
Weight decreased
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.35%
2/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.52%
3/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.52%
3/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Headache
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Memory impairment
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Restless legs syndrome
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Renal and urinary disorders
Dysuria
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Renal and urinary disorders
Nephrocalcinosis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.35%
2/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.52%
3/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.35%
2/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.36%
2/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.35%
2/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.17%
1/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Social circumstances
Dental prosthesis user
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Vascular disorders
Hypertension
|
1.4%
8/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.54%
3/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.35%
2/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.17%
1/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
|
Vascular disorders
Haematoma
|
0.00%
0/576 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/559 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.00%
0/575 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
0.18%
1/558 • AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic assessment).
|
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