Trial Outcomes & Findings for Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea (NCT NCT01766206)
NCT ID: NCT01766206
Last Updated: 2018-09-21
Results Overview
Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3948 participants
Primary outcome timeframe
From Day 1 of vaccination to Day 7 post vaccination
Results posted on
2018-09-21
Participant Flow
Healthy subjects from 2 months to 55 years of age were enrolled in 46 centres in South Korea.
Out of the 3,948 subjects enrolled, only 3,939 subjects were exposed to vaccination as 1 subject did not receive a study vaccination and 8 subjects did not provide post vaccination safety data. Among 3939 subjects, 15 subjects are in the ≥ 56 age category (outside the range defined as per the protocol).
Participant milestones
| Measure |
MenACWY-CRM Group
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Overall Study
STARTED
|
3939
|
|
Overall Study
COMPLETED
|
3888
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
MenACWY-CRM Group
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
22
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Inappropriate enrollment
|
18
|
|
Overall Study
Withdrawal and inappropriate enrollment
|
1
|
Baseline Characteristics
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Baseline characteristics by cohort
| Measure |
MenACWY-CRM Group
n=3939 Participants
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Age, Continuous
|
18.37 Years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Age, Customized
2- 23 months
|
654 Participants
n=5 Participants
|
|
Age, Customized
2-10 years
|
890 Participants
n=5 Participants
|
|
Age, Customized
2-5 years
|
551 Participants
n=5 Participants
|
|
Age, Customized
6-10 years
|
339 Participants
n=5 Participants
|
|
Age, Customized
11-18 years
|
433 Participants
n=5 Participants
|
|
Age, Customized
19-34 years
|
1286 Participants
n=5 Participants
|
|
Age, Customized
35 - 55 years
|
661 Participants
n=5 Participants
|
|
Age, Customized
≥ 56 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2181 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1758 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3937 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of vaccination to Day 7 post vaccinationPopulation: This analysis was performed on the Safety per protocol set, which included enrolled subjects aged from 2 months to 55 years, who signed an informed consent, underwent screening, received a subject number and received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Outcome measures
| Measure |
MenACWY-CRM Group
n=3920 Participants
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any irritability, 2 - 23 months
|
219 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any diarrhea, 2 - 5 years
|
7 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any rash, 2 - 5 years
|
18 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any fever, 2 - 5 years
|
12 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any nausea, 6 - 10 years
|
7 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any fever, 6 - 10 years
|
9 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any chills, 11 - 18 years
|
9 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any myalgia, 11 - 18 years
|
12 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any fever, 11 - 18 years
|
4 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injenction site tenderness, 19 - 34 years
|
214 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site induration, 19 - 34 years
|
9 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any chills, 19 - 34 years
|
7 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any nausea, 19 - 34 years
|
6 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any fever, 19 - 34 years
|
3 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site tenderness, 35 - 55 years
|
174 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any nausea, 35 - 55 years
|
9 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any malaise, 35 - 55 years
|
16 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any rash, 35 - 55 years
|
6 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any fever, 35 - 55 years
|
2 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site tenderness, 2 - 23 months
|
67 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site erythema, 2 - 23 months
|
32 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site induration, 2 - 23 months
|
28 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any change in eating habbits, 2 - 23 months
|
110 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any sleepiness, 2 - 23 months
|
126 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any vomiting, 2 - 23 months
|
66 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any diarrhea, 2 - 23 months
|
82 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any rash, 2 - 23 months
|
20 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any fever, 2 - 23 months
|
57 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site tenderness, 2 - 5 years
|
135 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site erythema, 2 - 5 years
|
71 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site induration, 2 - 5 years
|
49 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any change in eating habits, 2 - 5 years
|
22 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any sleepiness, 2 - 5 years
|
17 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any irritability, 2 - 5 years
|
35 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any vomiting, 2 - 5 years
|
4 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site tenderness, 6 - 10 years
|
108 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site erythema, 6 - 10 years
|
53 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site induration, 6 - 10 years
|
45 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any chills, 6 - 10 years
|
7 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any malaise, 6 - 10 years
|
5 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any myalgia, 6 - 10 years
|
6 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any arthralgia, 6 - 10 years
|
6 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any headache, 6 - 10 years
|
11 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any rash, 6 - 10 years
|
10 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site tenderness, 11 - 18 years
|
91 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site erythema, 11 - 18 years
|
17 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site induration, 11 - 18 years
|
21 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any nausea, 11 - 18 years
|
4 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any malaise, 11 - 18 years
|
9 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any arthralgia, 11 - 18 years
|
5 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any headache, 11 - 18 years
|
12 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any rash, 11 - 18 years
|
6 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site erythema, 19 - 34 years
|
14 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any malaise, 19 - 34 years
|
20 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any myalgia, 19 - 34 years
|
21 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any arthralgia, 19 - 34 years
|
8 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any headache, 19 - 34 years
|
29 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any rash, 19 - 34 years
|
13 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site erythema, 35 - 55 years
|
7 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any injection site induration, 35 - 55 years
|
6 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any chills, 35 - 55 years
|
7 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any myalgia, 35 - 55 years
|
23 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any arthralgia, 35 - 55 years
|
15 Participants
|
|
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Any headache, 35 - 55 years
|
19 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of vaccination to Day 7 post vaccinationPopulation: This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent,underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Outcome measures
| Measure |
MenACWY-CRM Group
n=3920 Participants
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
2 - 23 Months
|
82 Participants
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
2 - 5 Years
|
56 Participants
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
6 - 10 Years
|
18 Participants
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
19 - 34 Years
|
17 Participants
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
35 - 55 Years
|
5 Participants
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
11 - 18 Years
|
8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of vaccination to study termination (Day 29/early termination)Population: This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Outcome measures
| Measure |
MenACWY-CRM Group
n=3920 Participants
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Number of Subjects Reporting Medically Attended AEs (MAAEs)
2 - 23 Months
|
238 Participants
|
|
Number of Subjects Reporting Medically Attended AEs (MAAEs)
2 - 5 Years
|
120 Participants
|
|
Number of Subjects Reporting Medically Attended AEs (MAAEs)
6 - 10 Years
|
28 Participants
|
|
Number of Subjects Reporting Medically Attended AEs (MAAEs)
11 - 18 Years
|
20 Participants
|
|
Number of Subjects Reporting Medically Attended AEs (MAAEs)
35 - 55 Years
|
5 Participants
|
|
Number of Subjects Reporting Medically Attended AEs (MAAEs)
19 - 34 Years
|
16 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of vaccination to study termination (Day 29/early termination)Population: This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Outcome measures
| Measure |
MenACWY-CRM Group
n=3920 Participants
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Number of Subjects Reporting Serious AEs (SAEs)
2 - 23 Months
|
3 Participants
|
|
Number of Subjects Reporting Serious AEs (SAEs)
2 - 5 Years
|
3 Participants
|
|
Number of Subjects Reporting Serious AEs (SAEs)
6 - 10 Years
|
0 Participants
|
|
Number of Subjects Reporting Serious AEs (SAEs)
11 - 18 Years
|
2 Participants
|
|
Number of Subjects Reporting Serious AEs (SAEs)
19 - 34 Years
|
0 Participants
|
|
Number of Subjects Reporting Serious AEs (SAEs)
35 - 55 Years
|
0 Participants
|
Adverse Events
MenACWY-CRM Group
Serious events: 8 serious events
Other events: 1379 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY-CRM Group
n=3939 participants at risk
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
Infections and infestations
Bronchiolitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Pneumonia
|
0.10%
4/3939 • Number of events 4 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Tonsillitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Pyrexia
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
Other adverse events
| Measure |
MenACWY-CRM Group
n=3939 participants at risk
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
|
|---|---|
|
General disorders
Malaise
|
1.3%
53/3939 • Number of events 53 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Myalgia
|
1.6%
64/3939 • Number of events 64 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Arthralgia
|
0.86%
34/3939 • Number of events 34 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site tenderness
|
5.1%
202/3939 • Number of events 202 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site pain
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site erythema
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site induration
|
0.18%
7/3939 • Number of events 7 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Psychiatric disorders
Eating disorder
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Nervous system disorders
Sleepiness
|
3.6%
143/3939 • Number of events 143 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Psychiatric disorders
Irritability
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
8/3939 • Number of events 8 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Diarrhea
|
2.3%
89/3939 • Number of events 89 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Chills
|
0.79%
31/3939 • Number of events 31 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Nausea
|
0.71%
28/3939 • Number of events 28 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Nervous system disorders
Headache
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Fever
|
2.2%
87/3939 • Number of events 87 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Bronchitis
|
2.4%
94/3939 • Number of events 100 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
82/3939 • Number of events 93 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Pharyngitis
|
1.0%
40/3939 • Number of events 42 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Gastroenteritis
|
0.76%
30/3939 • Number of events 31 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Bronchiolitis
|
0.71%
28/3939 • Number of events 29 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Otitis media
|
0.56%
22/3939 • Number of events 22 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Pneumonia
|
0.38%
15/3939 • Number of events 16 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Rhinitis
|
0.33%
13/3939 • Number of events 13 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Conjunctivitis
|
0.30%
12/3939 • Number of events 12 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Tonsillitis
|
0.43%
17/3939 • Number of events 17 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.28%
11/3939 • Number of events 11 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Influenza
|
0.20%
8/3939 • Number of events 8 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Cellulitis
|
0.15%
6/3939 • Number of events 6 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Acute sinusitis
|
0.13%
5/3939 • Number of events 5 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Herpangina
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Laryngitis
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Viral pharyngitis
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Cystitis
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Oral herpes
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Periodontitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Sinusitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Pyrexia
|
0.38%
15/3939 • Number of events 17 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site pruritus
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site warmth
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Oedema peripheral
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Chest pain
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site bruising
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site swelling
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Enteritis
|
0.56%
22/3939 • Number of events 23 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
7/3939 • Number of events 7 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Constipation
|
0.18%
7/3939 • Number of events 7 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Stomatitis
|
0.18%
7/3939 • Number of events 7 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Colitis
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Dental caries
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.51%
20/3939 • Number of events 20 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.28%
11/3939 • Number of events 11 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.25%
10/3939 • Number of events 12 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.20%
8/3939 • Number of events 8 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.46%
18/3939 • Number of events 18 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
8/3939 • Number of events 8 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Nervous system disorders
Burning sensation
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Eye disorders
Conjunctivitis allergic
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Eye disorders
Eye discharge
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Eye disorders
Ocular hyperaemia
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Blood and lymphatic system disorders
Lymphadentitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Renal and urinary disorders
Haematuria
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Renal and urinary disorders
Renal cyst
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Reproductive system and breast disorders
Prostatic cyst
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Vascular disorders
Orthostatic hypotension
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Impetigo
|
0.13%
5/3939 • Number of events 5 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Herpes dermatitis
|
0.10%
4/3939 • Number of events 4 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Otitis media acute
|
0.10%
4/3939 • Number of events 4 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Oral candidiasis
|
0.08%
3/3939 • Number of events 3 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Pharyngitis bacterial
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Tracheitis
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Bacterial infection
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Croup infectious
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Exanthema subitum
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Gastrointestinal infection
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Hordeolum
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Infections and infestations
Urinary tract infection
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
General disorders
Injection site rash
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
6/3939 • Number of events 6 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
2/3939 • Number of events 2 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Eye disorders
Keratitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Ear and labyrinth disorders
Ear pain
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Immune system disorders
Atopy
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Nervous system disorders
Somnolence
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
|
Nervous system disorders
sleepiness
|
0.03%
1/3939 • Number of events 1 • Solicited and unsolicited AEs were reported from Day 1 to Day 7. MAAEs and SAEs were reported from study day 1 to study termination (Day 29/early termination).
Total number of subjects at risk for SAEs, all cause mortality and FAEs were analyzed from the Safety set (including 15 subjects of ≥ 56 years age category).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER