Trial Outcomes & Findings for Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune® (NCT NCT00850603)
NCT ID: NCT00850603
Last Updated: 2016-04-14
Results Overview
Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
170 participants
Primary outcome timeframe
Baseline to 28 days post vaccination
Results posted on
2016-04-14
Participant Flow
Study participants were enrolled from 15 through 16 October 2002 in 1 US site
A total of 170 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
0.5 mL Subcutaneous Menomune®
Participants received 0.5 mL Subcutaneous Menomune®
|
0.1 mL Subcutaneous Menomune®
Participants received 0.1 mL Subcutaneous Menomune®
|
0.05 mL Intradermal Menomune®
Participants received 0.05 mL Intradermal Menomune®
|
0.1 mL Intradermal Menomune®
Participants received 0.1 mL Intradermal Menomune®
|
0.15 mL Intradermal Menomune®
Participants received 0.15 mL Intradermal Menomune®
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
34
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
34
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Baseline characteristics by cohort
| Measure |
0.5 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.5 mL Subcutaneous Menomune®
|
0.1 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.1 mL Subcutaneous Menomune®
|
0.05 mL Intradermal Menomune®
n=34 Participants
Participants received 0.05 mL Intradermal Menomune®
|
0.1 mL Intradermal Menomune®
n=34 Participants
Participants received 0.1 mL Intradermal Menomune®
|
0.15 mL Intradermal Menomune®
n=34 Participants
Participants received 0.15 mL Intradermal Menomune®
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
159 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 7.10 • n=7 Participants
|
24.4 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 8.46 • n=4 Participants
|
28.9 years
STANDARD_DEVIATION 12.85 • n=21 Participants
|
25.6 years
STANDARD_DEVIATION 9.42 • n=8 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
93 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
77 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
34 participants
n=4 Participants
|
34 participants
n=21 Participants
|
170 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to 28 days post vaccinationPopulation: 4-Fold rise analysis was in the per-protocol population with valid serology data
Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Outcome measures
| Measure |
0.5 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.5 mL Subcutaneous Menomune®
|
0.1 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.1 mL Subcutaneous Menomune®
|
0.05 mL Intradermal Menomune®
n=34 Participants
Participants received 0.05 mL Intradermal Menomune®
|
0.1 mL Intradermal Menomune®
n=34 Participants
Participants received 0.1 mL Intradermal Menomune®
|
0.15 mL Intradermal Menomune®
n=34 Participants
Participants received 0.15 mL Intradermal Menomune®
|
|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Meningococcal serogroup A
|
85 Percentage of participants
|
61 Percentage of participants
|
61 Percentage of participants
|
76 Percentage of participants
|
84 Percentage of participants
|
|
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Meningococcal serogroup C
|
79 Percentage of participants
|
58 Percentage of participants
|
67 Percentage of participants
|
70 Percentage of participants
|
88 Percentage of participants
|
|
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Meningococcal serogroup Y
|
64 Percentage of participants
|
68 Percentage of participants
|
61 Percentage of participants
|
58 Percentage of participants
|
66 Percentage of participants
|
|
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Meningococcal serogroup W-135
|
88 Percentage of participants
|
77 Percentage of participants
|
73 Percentage of participants
|
79 Percentage of participants
|
97 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Day 28 post-vaccinationPopulation: Geometric mean titers were determined in the per-protocol population.
GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
Outcome measures
| Measure |
0.5 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.5 mL Subcutaneous Menomune®
|
0.1 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.1 mL Subcutaneous Menomune®
|
0.05 mL Intradermal Menomune®
n=34 Participants
Participants received 0.05 mL Intradermal Menomune®
|
0.1 mL Intradermal Menomune®
n=34 Participants
Participants received 0.1 mL Intradermal Menomune®
|
0.15 mL Intradermal Menomune®
n=34 Participants
Participants received 0.15 mL Intradermal Menomune®
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup A (Day 0)
|
462.4 Titers
Interval 222.4 to 961.4
|
320.4 Titers
Interval 127.7 to 803.8
|
267.0 Titers
Interval 114.5 to 622.7
|
381.6 Titers
Interval 195.7 to 743.8
|
261.6 Titers
Interval 131.1 to 522.1
|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup A (Day 28)
|
5496.3 Titers
Interval 3262.8 to 9258.7
|
3662.7 Titers
Interval 2392.4 to 5607.7
|
1775.6 Titers
Interval 1116.3 to 2824.5
|
3079.0 Titers
Interval 2298.4 to 4124.7
|
4013.3 Titers
Interval 2575.7 to 6253.4
|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup Y (Day 0)
|
301.3 Titers
Interval 138.3 to 656.5
|
166.8 Titers
Interval 73.0 to 381.5
|
164.7 Titers
Interval 73.3 to 370.2
|
216.4 Titers
Interval 103.8 to 451.2
|
189.0 Titers
Interval 93.5 to 382.1
|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup Y (Day 28)
|
1883.0 Titers
Interval 1185.2 to 2991.4
|
2002.7 Titers
Interval 1163.3 to 3447.9
|
1390.3 Titers
Interval 742.1 to 2604.8
|
1603.6 Titers
Interval 1111.6 to 2313.3
|
1887.6 Titers
Interval 1120.4 to 3180.3
|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup W-135 (Day 0)
|
32.7 Titers
Interval 15.3 to 69.8
|
37.7 Titers
Interval 19.0 to 74.7
|
47.7 Titers
Interval 24.5 to 93.0
|
34.1 Titers
Interval 16.0 to 72.8
|
19.4 Titers
Interval 9.7 to 38.9
|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup W-135 (Day 28)
|
1374.1 Titers
Interval 846.9 to 2229.4
|
856.3 Titers
Interval 465.9 to 1573.8
|
1390.3 Titers
Interval 805.1 to 2400.9
|
1307.8 Titers
Interval 881.6 to 1940.2
|
2006.7 Titers
Interval 1204.5 to 3343.0
|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup C (Day 0)
|
48.1 Titers
Interval 20.1 to 115.0
|
85.1 Titers
Interval 34.6 to 209.7
|
50.8 Titers
Interval 20.7 to 124.4
|
53.0 Titers
Interval 21.6 to 129.7
|
41.5 Titers
Interval 18.8 to 91.4
|
|
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Meningococcal serogroup C (Day 28)
|
2989.0 Titers
Interval 1475.1 to 6056.5
|
1751.3 Titers
Interval 934.0 to 3283.8
|
1478.0 Titers
Interval 647.4 to 3374.3
|
1307.8 Titers
Interval 661.8 to 2584.4
|
2780.6 Titers
Interval 1428.3 to 5413.2
|
SECONDARY outcome
Timeframe: Day 0 to 7 days post-vaccinationParticipants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®
Outcome measures
| Measure |
0.5 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.5 mL Subcutaneous Menomune®
|
0.1 mL Subcutaneous Menomune®
n=34 Participants
Participants received 0.1 mL Subcutaneous Menomune®
|
0.05 mL Intradermal Menomune®
n=34 Participants
Participants received 0.05 mL Intradermal Menomune®
|
0.1 mL Intradermal Menomune®
n=34 Participants
Participants received 0.1 mL Intradermal Menomune®
|
0.15 mL Intradermal Menomune®
n=34 Participants
Participants received 0.15 mL Intradermal Menomune®
|
|---|---|---|---|---|---|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Myalgia
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Vomiting
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Vomiting (≥3 episodes)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Diarrhea
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Diarrhea (≥3 episodes)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Arthralgia
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Arthralgia (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Injection site Rash
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Myalgia (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Nausea
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Nausea (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Grade 3 Local Reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Redness
|
2 Participants
|
2 Participants
|
8 Participants
|
9 Participants
|
18 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Redness ( ≥ 2 inchs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Tenderness
|
6 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Tenderness (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Pain (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Systemic Reaction
|
4 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Grade 3 Systemic Reaction
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Fever (≥ 39.6 ºC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Chills
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Chills (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Headache
|
2 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Headache (disabling)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Malaise
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Malaise (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Local Reaction
|
8 Participants
|
5 Participants
|
9 Participants
|
10 Participants
|
18 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Swelling
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
10 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Swelling ( ≥ 2 inchs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Any Dizziness
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Grade 3 Dizziness (disabling)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
0.5 mL Subcutaneous Menomune®
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
0.1 mL Subcutaneous Menomune®
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
0.05 mL Intradermal Menomune®
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
0.1 mL Intradermal Menomune®
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
0.15 mL Intradermal Menomune®
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.5 mL Subcutaneous Menomune®
n=34 participants at risk
Participants received 0.5 mL Subcutaneous Menomune®
|
0.1 mL Subcutaneous Menomune®
n=34 participants at risk
Participants received 0.1 mL Subcutaneous Menomune®
|
0.05 mL Intradermal Menomune®
n=34 participants at risk
Participants received 0.05 mL Intradermal Menomune®
|
0.1 mL Intradermal Menomune®
n=34 participants at risk
Participants received 0.1 mL Intradermal Menomune®
|
0.15 mL Intradermal Menomune®
n=34 participants at risk
Participants received 0.15 mL Intradermal Menomune®
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain NOS
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
Other adverse events
| Measure |
0.5 mL Subcutaneous Menomune®
n=34 participants at risk
Participants received 0.5 mL Subcutaneous Menomune®
|
0.1 mL Subcutaneous Menomune®
n=34 participants at risk
Participants received 0.1 mL Subcutaneous Menomune®
|
0.05 mL Intradermal Menomune®
n=34 participants at risk
Participants received 0.05 mL Intradermal Menomune®
|
0.1 mL Intradermal Menomune®
n=34 participants at risk
Participants received 0.1 mL Intradermal Menomune®
|
0.15 mL Intradermal Menomune®
n=34 participants at risk
Participants received 0.15 mL Intradermal Menomune®
|
|---|---|---|---|---|---|
|
General disorders
Injection site redness
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
23.5%
8/34 • Number of events 8 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
26.5%
9/34 • Number of events 9 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
52.9%
18/34 • Number of events 18 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
General disorders
Injection site swelling
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
11.8%
4/34 • Number of events 4 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
14.7%
5/34 • Number of events 5 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
29.4%
10/34 • Number of events 10 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
General disorders
Injection site tenderness
|
17.6%
6/34 • Number of events 6 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
11.8%
4/34 • Number of events 4 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
8.8%
3/34 • Number of events 3 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Chills
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
17.6%
6/34 • Number of events 6 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
8.8%
3/34 • Number of events 3 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
General disorders
Malaise
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
8.8%
3/34 • Number of events 3 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
0.00%
0/34 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
11.8%
4/34 • Number of events 4 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
5.9%
2/34 • Number of events 2 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination
|
2.9%
1/34 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days 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