Trial Outcomes & Findings for Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26 (NCT NCT00700713)
NCT ID: NCT00700713
Last Updated: 2016-02-15
Results Overview
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 30 post-vaccination
Results posted on
2016-02-15
Participant Flow
Study participants were enrolled from 17 June 2008 to 01 October 2008 at 13 clinical centers in the United States.
A total of 181 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
One-Dose Menactra Group
Participants received one dose of Menactra® in Study MTA26.
|
Two-Dose Menactra Group
Participants received two doses of Menactra® in Study MTA26.
|
Menactra-naïve Group
Participants had never received Menactra® vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
66
|
67
|
|
Overall Study
COMPLETED
|
47
|
66
|
65
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
One-Dose Menactra Group
Participants received one dose of Menactra® in Study MTA26.
|
Two-Dose Menactra Group
Participants received two doses of Menactra® in Study MTA26.
|
Menactra-naïve Group
Participants had never received Menactra® vaccine.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
Baseline characteristics by cohort
| Measure |
One-Dose Menactra Group
n=48 Participants
Participants received one dose of Menactra® in Study MTA26.
|
Two-Dose Menactra Group
n=66 Participants
Participants received two doses of Menactra® in Study MTA26
|
Menactra-naïve Group
n=67 Participants
Participants had never received Menactra® vaccine.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
48 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
57.4 Months
STANDARD_DEVIATION 2.89 • n=5 Participants
|
51.6 Months
STANDARD_DEVIATION 1.96 • n=7 Participants
|
52.5 Months
STANDARD_DEVIATION 11.8 • n=5 Participants
|
53.4 Months
STANDARD_DEVIATION 7.75 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
Outcome measures
| Measure |
One-Dose Menactra Group
n=41 Participants
Participants received one dose of Menactra® in Study MTA26.
|
Two-Dose Menactra Group
n=63 Participants
Participants received two doses of Menactra® in Study MTA26.
|
Menactra-naïve Group
n=61 Participants
Participants had never received Menactra® vaccine.
|
|---|---|---|---|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup A; Day 30, ≥1:4 (n=40, 62, 59)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
93.2 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup A; Day 30, ≥1:8 (n=40, 62, 59)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
84.8 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup W-135; Day 0, ≥1:4 (n=41, 63, 61)
|
43.9 Percentage of participants
|
49.2 Percentage of participants
|
14.8 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup A; Day 0, ≥1:4 (n=41, 63, 61)
|
70.7 Percentage of participants
|
76.2 Percentage of participants
|
50.8 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup A; Day 0, ≥1:8 (n=41, 63, 61)
|
48.8 Percentage of participants
|
46.0 Percentage of participants
|
18.0 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup C; Day 0, ≥1:4 (n=41, 63, 61)
|
29.3 Percentage of participants
|
20.6 Percentage of participants
|
9.8 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup C; Day 0, ≥1:8 (n=41, 63, 61)
|
22.0 Percentage of participants
|
12.7 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup C; Day 30, ≥1:4 (n=41, 63, 59)
|
100.0 Percentage of participants
|
98.4 Percentage of participants
|
59.3 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup C; Day 30, ≥1:8 (n=41, 63, 59)
|
100.0 Percentage of participants
|
98.4 Percentage of participants
|
54.2 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup Y; Day 0, ≥1:4 (n=41, 63, 61)
|
31.7 Percentage of participants
|
33.3 Percentage of participants
|
6.6 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup Y; Day 0, ≥1:8 (n=41, 63, 61)
|
14.6 Percentage of participants
|
14.3 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup Y; Day 30, ≥1:4 (n=40, 63, 60)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
81.7 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup Y; Day 30, ≥1:8 (n=40, 63, 60)
|
100.0 Percentage of participants
|
98.4 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup W-135; Day 0, ≥1:8 (n=41, 63, 61)
|
29.3 Percentage of participants
|
22.2 Percentage of participants
|
8.2 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup W-135; Day 30, ≥1:4 (n=40, 63, 60)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
83.3 Percentage of participants
|
|
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Serogroup W-135; Day 30, ≥1:8 (n=40, 63, 60)
|
100.0 Percentage of participants
|
98.4 Percentage of participants
|
73.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccinationPopulation: Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).
Outcome measures
| Measure |
One-Dose Menactra Group
n=41 Participants
Participants received one dose of Menactra® in Study MTA26.
|
Two-Dose Menactra Group
n=63 Participants
Participants received two doses of Menactra® in Study MTA26.
|
Menactra-naïve Group
n=61 Participants
Participants had never received Menactra® vaccine.
|
|---|---|---|---|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup C; Day 0 (N=41, 63, 61)
|
4.4 Titers (1/dilutions)
Interval 2.6 to 7.3
|
2.9 Titers (1/dilutions)
Interval 2.3 to 3.6
|
2.2 Titers (1/dilutions)
Interval 2.0 to 2.4
|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup A; Day 0 (N=41, 63, 61)
|
6.2 Titers (1/dilutions)
Interval 4.4 to 8.8
|
7.4 Titers (1/dilutions)
Interval 5.4 to 10.2
|
3.5 Titers (1/dilutions)
Interval 2.9 to 4.3
|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup A; Day 30 (N=40, 62, 59)
|
200.9 Titers (1/dilutions)
Interval 134.2 to 300.6
|
234.1 Titers (1/dilutions)
Interval 162.4 to 337.4
|
15.6 Titers (1/dilutions)
Interval 11.7 to 20.9
|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup C; Day 30 (N=41, 63, 59)
|
606.3 Titers (1/dilutions)
Interval 422.1 to 870.9
|
397.5 Titers (1/dilutions)
Interval 283.9 to 556.6
|
9.5 Titers (1/dilutions)
Interval 6.2 to 14.6
|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup Y; Day 0 (N=41, 63, 61)
|
3.0 Titers (1/dilutions)
Interval 2.3 to 3.7
|
3.1 Titers (1/dilutions)
Interval 2.5 to 3.9
|
2.1 Titers (1/dilutions)
Interval 2.0 to 2.3
|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup Y; Day 30 (N=40, 63, 60)
|
530.1 Titers (1/dilutions)
Interval 374.4 to 750.4
|
264.6 Titers (1/dilutions)
Interval 193.6 to 361.7
|
13.5 Titers (1/dilutions)
Interval 9.6 to 18.9
|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup W-135; Day 0 (n=41, 63, 61)
|
4.1 Titers (1/dilutions)
Interval 3.0 to 5.8
|
3.7 Titers (1/dilutions)
Interval 3.0 to 4.5
|
2.5 Titers (1/dilutions)
Interval 2.1 to 2.9
|
|
Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Serogroup W-135; Day 30 (N=40, 63, 60)
|
332.0 Titers (1/dilutions)
Interval 200.1 to 550.8
|
256.0 Titers (1/dilutions)
Interval 180.8 to 362.5
|
14.9 Titers (1/dilutions)
Interval 10.5 to 21.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) -\>39.0˚C (\>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - \>3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.
Outcome measures
| Measure |
One-Dose Menactra Group
n=48 Participants
Participants received one dose of Menactra® in Study MTA26.
|
Two-Dose Menactra Group
n=66 Participants
Participants received two doses of Menactra® in Study MTA26.
|
Menactra-naïve Group
n=67 Participants
Participants had never received Menactra® vaccine.
|
|---|---|---|---|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Injection-site Swelling (N=47, 66, 65)
|
8.5 Percentage of participants
|
3.0 Percentage of participants
|
12.3 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Headache (N=47, 66, 65)
|
8.5 Percentage of participants
|
10.6 Percentage of participants
|
6.2 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Injection-site Pain (N=47, 66, 65)
|
55.3 Percentage of participants
|
65.2 Percentage of participants
|
63.1 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Injection-site Pain (N=47, 66, 65)
|
2.1 Percentage of participants
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Injection-site Erythema (N=47, 66, 65)
|
23.4 Percentage of participants
|
39.4 Percentage of participants
|
38.5 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Injection-site Erythema (N=47, 66, 65)
|
6.4 Percentage of participants
|
6.1 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Injection-site Swelling (N=47, 66, 65)
|
19.1 Percentage of participants
|
30.3 Percentage of participants
|
32.3 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Fever (N=47, 66, 65)
|
12.8 Percentage of participants
|
6.1 Percentage of participants
|
4.6 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Fever (N=47, 66, 65)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Headache (N=47, 66, 65)
|
2.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Vomiting (N=47, 66, 65)
|
6.4 Percentage of participants
|
1.5 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Vomiting (n=47, 66, 65)
|
0.0 Percentage of participants
|
1.5 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Drowsiness (N=47, 66, 65)
|
19.1 Percentage of participants
|
24.2 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Drowsiness (N=47, 66, 65)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Anorexia (n=47, 66, 65)
|
4.3 Percentage of participants
|
12.1 Percentage of participants
|
18.5 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Anorexia (N=47, 66, 65)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Irritability (N=47, 66, 65)
|
19.1 Percentage of participants
|
30.3 Percentage of participants
|
33.8 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Irritability (N=47, 66, 65)
|
2.1 Percentage of participants
|
1.5 Percentage of participants
|
4.6 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Arthralgia (n=47, 66, 65)
|
8.5 Percentage of participants
|
13.6 Percentage of participants
|
16.9 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Arthralgia (N=47, 66, 65)
|
2.1 Percentage of participants
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Diarrhea (N=47, 66, 65)
|
8.5 Percentage of participants
|
10.6 Percentage of participants
|
9.2 Percentage of participants
|
|
Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Diarrhea (N=47, 66, 65)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
One-Dose Menactra Group
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Two-Dose Menactra Group
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Menactra-naïve Group
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
One-Dose Menactra Group
n=48 participants at risk
Participants received one dose of Menactra® in Study MTA26.
|
Two-Dose Menactra Group
n=66 participants at risk
Participants received two doses of Menactra® in Study MTA26.
|
Menactra-naïve Group
n=67 participants at risk
Participants had never received Menactra® vaccine.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
8.3%
4/48 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
1.5%
1/66 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
6.0%
4/67 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
5/48 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
6.1%
4/66 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
General disorders
Injection-site Pain
|
55.3%
26/47 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
65.2%
43/66 • Number of events 43 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
63.1%
41/65 • Number of events 41 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
General disorders
Injection-site Erythema
|
23.4%
11/47 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
39.4%
26/66 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
38.5%
25/65 • Number of events 25 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
General disorders
Injection-site Swelling
|
19.1%
9/47 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
30.3%
20/66 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
32.3%
21/65 • Number of events 21 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
General disorders
Fever
|
12.8%
6/47 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
6.1%
4/66 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
4.6%
3/65 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Nervous system disorders
Headache
|
8.5%
4/47 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
10.6%
7/66 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
6.2%
4/65 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
1.5%
1/66 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
3.1%
2/65 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Nervous system disorders
Drowsiness
|
19.1%
9/47 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
24.2%
16/66 • Number of events 16 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
10.8%
7/65 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
2/47 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
12.1%
8/66 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
18.5%
12/65 • Number of events 12 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Psychiatric disorders
Irritability
|
19.1%
9/47 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
30.3%
20/66 • Number of events 20 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
33.8%
22/65 • Number of events 22 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
4/47 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
13.6%
9/66 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
16.9%
11/65 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
4/47 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
10.6%
7/66 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
9.2%
6/65 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 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