Trial Outcomes & Findings for Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects (NCT NCT01519713)
NCT ID: NCT01519713
Last Updated: 2013-05-28
Results Overview
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
28 Days post-vaccination
Results posted on
2013-05-28
Participant Flow
Study participants were enrolled from 20 January through 25 February 2012 in 4 clinic sites in Japan.
A total of 200 subjects who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Adults Menactra® Vaccine Group
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
194
|
2
|
4
|
|
Overall Study
COMPLETED
|
194
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects
Baseline characteristics by cohort
| Measure |
Adults Menactra® Vaccine Group
n=194 Participants
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 Participants
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 Participants
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
194 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
35.6 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
11.0 Years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
4.3 Years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
34.7 Years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
194 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 Days post-vaccinationPopulation: Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.
Outcome measures
| Measure |
Adults Menactra® Vaccine Group
n=194 Participants
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 Participants
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 Participants
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup A (N = 194, 2, 4)
|
177 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup C (N = 192, 2, 4)
|
154 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup Y (N = 192, 2, 4)
|
180 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup W-135 (N = 193, 2, 4)
|
172 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 28 Days post-vaccinationPopulation: Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Adults Menactra® Vaccine Group
n=194 Participants
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 Participants
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 Participants
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup A (N = 194, 2, 4)
|
180 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup C (N = 192, 2, 4)
|
167 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup Y (N = 192, 2, 4)
|
190 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine
Serogroup W-135 (N = 193, 2, 4)
|
186 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 28 Days post-vaccinationPopulation: Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Adults Menactra® Vaccine Group
n=194 Participants
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 Participants
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 Participants
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.
Serogroup A (N = 193, 2, 4)
|
150 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.
Serogroup C (N = 191, 2, 4)
|
151 Participants
|
2 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.
Serogroup Y (N = 191, 2, 4)
|
139 Participants
|
1 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.
Serogroup W-135 (N = 192, 2, 4)
|
169 Participants
|
2 Participants
Interval 0.0 to 0.0
|
4 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Days 0 and 28 post-vaccinationPopulation: Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Adults Menactra® Vaccine Group
n=194 Participants
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 Participants
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 Participants
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup A (Day 0; N = 193, 2, 4)
|
26.0 Titers
Interval 17.4 to 38.9
|
2.0 Titers
Data was not computable, variance was zero because all participants had the same value.
|
2.0 Titers
Data was not computable, variance was zero because all participants had the same value.
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup A (Day 28; N = 194, 2, 4)
|
1202.6 Titers
Interval 876.2 to 1650.6
|
2896.3 Titers
Interval 35.4 to 236766.0
|
16384.0 Titers
Interval 1804.7 to 148741.4
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup C (Day 0; N = 193, 2, 4)
|
5.6 Titers
Interval 4.2 to 7.4
|
2 Titers
Data was not computable, variance was zero because all participants had the same value.
|
5.7 Titers
Interval 0.2 to 154.7
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup C (Day 28; N = 192, 2, 4)
|
389.1 Titers
Interval 274.4 to 551.8
|
2048.0 Titers
Interval 0.0 to 91459214176.9
|
512.0 Titers
Interval 208.0 to 1260.0
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup Y (Day 0; N = 193, 2, 4)
|
64.2 Titers
Interval 45.1 to 91.5
|
181.0 Titers
Interval 2.2 to 14797.9
|
107.6 Titers
Interval 26.9 to 431.2
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup Y (Day 28; N = 192, 2, 4)
|
1244.4 Titers
Interval 991.3 to 1562.2
|
724.1 Titers
Interval 0.0 to 395556106.8
|
3444.3 Titers
Interval 298.5 to 39740.1
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup W-135 (Day 0; N = 193, 2, 4)
|
12.8 Titers
Interval 9.3 to 17.6
|
128.0 Titers
Interval 0.0 to 855379.3
|
38.1 Titers
Interval 1.4 to 1025.1
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Serogroup W-135 (Day 28; N = 193, 2, 4)
|
995.0 Titers
Interval 737.9 to 1341.7
|
8192.0 Titers
Interval 1.2 to 54744273.9
|
9742.0 Titers
Interval 2431.7 to 39028.6
|
SECONDARY outcome
Timeframe: 28 Days post-vaccinationPopulation: Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Adults Menactra® Vaccine Group
n=194 Participants
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 Participants
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 Participants
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine
Serogroup A (N = 193, 2, 4)
|
31.9 Titers
Interval 21.7 to 46.8
|
724.1 Titers
Interval 8.9 to 59191.5
|
4096.0 Titers
Interval 451.2 to 37185.3
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine
Serogroup C (N = 191, 2, 4)
|
40.8 Titers
Interval 28.3 to 58.9
|
512.0 Titers
Interval 0.0 to 22864803544.2
|
53.8 Titers
Interval 1.6 to 1838.6
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine
Serogroup Y (N = 191, 2, 4)
|
16.1 Titers
Interval 11.6 to 22.2
|
4.0 Titers
Interval 0.0 to 26730.6
|
32.0 Titers
Interval 3.5 to 290.5
|
|
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine
Serogroup W-135 (N = 192, 2, 4)
|
53.6 Titers
Interval 38.9 to 73.9
|
64.0 Titers
Data was not computable, variance was zero because all participants had the same value.
|
215.3 Titers
Interval 3.3 to 13841.7
|
SECONDARY outcome
Timeframe: Day 0 up to Day 28 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities.
Outcome measures
| Measure |
Adults Menactra® Vaccine Group
n=194 Participants
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 Participants
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 Participants
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Any injection site Pain
|
60 Participants
|
0 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Grade 3 injection site Pain
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Any injection site Erythema
|
5 Participants
|
2 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Grade 3 injection site Erythema
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Any injection site Swelling
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Grade 3 injection site Swelling
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Any Fever
|
3 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Grade 3 Fever
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Any Headache
|
22 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Grade 3 Headache
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Any Malaise
|
30 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Grade 3 Malaise
|
3 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Any Myalgia
|
48 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Grade 3 Myalgia
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
Adverse Events
Adults Menactra® Vaccine Group
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Adolescents Menactra® Vaccine Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Children Menactra® Vaccine Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adults Menactra® Vaccine Group
n=194 participants at risk
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
|
Adolescents Menactra® Vaccine Group
n=2 participants at risk
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
|
Children Menactra® Vaccine Group
n=4 participants at risk
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
|
|---|---|---|---|
|
General disorders
Injection site pain
|
30.9%
60/194 • Number of events 60 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
75.0%
3/4 • Number of events 3 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
|
General disorders
Injection site erythema
|
2.6%
5/194 • Number of events 5 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
100.0%
2/2 • Number of events 2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
75.0%
3/4 • Number of events 3 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
|
General disorders
Injection site swelling
|
1.0%
2/194 • Number of events 2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
100.0%
2/2 • Number of events 2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
75.0%
3/4 • Number of events 3 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
|
General disorders
Malaise
|
15.5%
30/194 • Number of events 30 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/4 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.7%
48/194 • Number of events 48 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/4 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
15/194 • Number of events 17 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/4 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
|
Infections and infestations
Otitis media
|
0.00%
0/194 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/2 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
25.0%
1/4 • Number of events 1 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/194 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
50.0%
1/2 • Number of events 1 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
0.00%
0/4 • Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER