Trial Outcomes & Findings for Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents (NCT NCT00262041)
NCT ID: NCT00262041
Last Updated: 2018-06-28
Results Overview
Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
524 participants
Primary outcome timeframe
1 month after vaccination
Results posted on
2018-06-28
Participant Flow
Subjects were enrolled at Seattle, Washington; Pittsburgh, Pennsylvania; Rochester, Minnesota.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
MenACWY-CRM(Ad+)
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS
Subjects received one single dose of the MenACWY polysaccharide vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
164
|
151
|
209
|
|
Overall Study
COMPLETED
|
162
|
147
|
203
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
6
|
Reasons for withdrawal
| Measure |
MenACWY-CRM(Ad+)
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS
Subjects received one single dose of the MenACWY polysaccharide vaccine.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
5
|
|
Overall Study
Unable to classify
|
1
|
0
|
0
|
Baseline Characteristics
Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
Baseline characteristics by cohort
| Measure |
MenACWY-CRM(Ad+)
n=164 Participants
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=151 Participants
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS - Stage 1
n=170 Participants
Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
|
MenACWY-PS -Stage 2
n=39 Participants
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
|
Total
n=524 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
14.2 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
14.2 years
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
209 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
315 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation.
Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y
Outcome measures
| Measure |
MenACWY-CRM(Ad+)
n=161 Participants
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=148 Participants
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS
n=179 Participants
Subjects received one single dose of the MenACWY polysaccharide vaccine.
|
MenACWY-PS -Stage 2
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
|
|---|---|---|---|---|
|
Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
MenA (N=158,148,179)
|
87 Percentages Of Subjects
Interval 80.0 to 92.0
|
84 Percentages Of Subjects
Interval 77.0 to 89.0
|
46 Percentages Of Subjects
Interval 38.0 to 53.0
|
—
|
|
Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
MenC (N=161,148,177)
|
93 Percentages Of Subjects
Interval 87.0 to 96.0
|
88 Percentages Of Subjects
Interval 81.0 to 93.0
|
71 Percentages Of Subjects
Interval 64.0 to 78.0
|
—
|
|
Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
MenW (N=161,146,173)
|
98 Percentages Of Subjects
Interval 94.0 to 99.0
|
95 Percentages Of Subjects
Interval 90.0 to 98.0
|
88 Percentages Of Subjects
Interval 83.0 to 93.0
|
—
|
|
Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
MenY (N=159, 147,177)
|
97 Percentages Of Subjects
Interval 93.0 to 99.0
|
96 Percentages Of Subjects
Interval 91.0 to 98.0
|
84 Percentages Of Subjects
Interval 77.0 to 89.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Analysis was done on per-protocol population.
Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.
Outcome measures
| Measure |
MenACWY-CRM(Ad+)
n=161 Participants
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=148 Participants
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS
n=179 Participants
Subjects received one single dose of the MenACWY polysaccharide vaccine.
|
MenACWY-PS -Stage 2
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
|
|---|---|---|---|---|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine
MenA (N=158, 148, 179)
|
34 Titers
Interval 26.0 to 43.0
|
34 Titers
Interval 26.0 to 44.0
|
6.97 Titers
Interval 5.51 to 8.82
|
—
|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine
MenC (N=161, 148, 177)
|
69 Titers
Interval 48.0 to 100.0
|
58 Titers
Interval 39.0 to 85.0
|
30 Titers
Interval 22.0 to 43.0
|
—
|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine
MenW (161, 146, 173)
|
61 Titers
Interval 49.0 to 75.0
|
49 Titers
Interval 39.0 to 62.0
|
30 Titers
Interval 24.0 to 37.0
|
—
|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine
MenY (159,147,177)
|
112 Titers
Interval 85.0 to 147.0
|
100 Titers
Interval 75.0 to 133.0
|
34 Titers
Interval 27.0 to 44.0
|
—
|
SECONDARY outcome
Timeframe: 12 months after vaccinationPopulation: Analysis was done on PP population.
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
Outcome measures
| Measure |
MenACWY-CRM(Ad+)
n=140 Participants
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=149 Participants
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS
Subjects received one single dose of the MenACWY polysaccharide vaccine.
|
MenACWY-PS -Stage 2
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenA (N=140, 149)
|
36 Percentages Of Subjects
Interval 28.0 to 44.0
|
44 Percentages Of Subjects
Interval 36.0 to 53.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenC (N=140, 147)
|
86 Percentages Of Subjects
Interval 79.0 to 91.0
|
69 Percentages Of Subjects
Interval 61.0 to 76.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenW (N=138, 141)
|
95 Percentages Of Subjects
Interval 90.0 to 98.0
|
72 Percentages Of Subjects
Interval 63.0 to 79.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenY (N=139, 147)
|
87 Percentages Of Subjects
Interval 80.0 to 92.0
|
63 Percentages Of Subjects
Interval 54.0 to 70.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months after vaccinationPopulation: Analysis was done on PP population.
Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
Outcome measures
| Measure |
MenACWY-CRM(Ad+)
n=140 Participants
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=149 Participants
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS
Subjects received one single dose of the MenACWY polysaccharide vaccine.
|
MenACWY-PS -Stage 2
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
|
|---|---|---|---|---|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenY (N=139, 147)
|
30 Titers
Interval 22.0 to 41.0
|
13 Titers
Interval 9.49 to 17.0
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenA(N=140, 149)
|
4.24 Titers
Interval 3.35 to 5.38
|
5.65 Titers
Interval 4.54 to 7.03
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenC (N=140, 147)
|
28 Titers
Interval 19.0 to 41.0
|
26 Titers
Interval 18.0 to 37.0
|
—
|
—
|
|
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
MenW (N=138, 141)
|
40 Titers
Interval 31.0 to 52.0
|
17 Titers
Interval 13.0 to 22.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data.
Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM(Ad+)
n=164 Participants
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=170 Participants
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS
n=151 Participants
Subjects received one single dose of the MenACWY polysaccharide vaccine.
|
MenACWY-PS -Stage 2
n=39 Participants
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
|
|---|---|---|---|---|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Any Local
|
103 Subjects
|
102 Subjects
|
107 Subjects
|
24 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Injection Site Pain
|
92 Subjects
|
95 Subjects
|
81 Subjects
|
19 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Injection Site Erythema
|
33 Subjects
|
28 Subjects
|
57 Subjects
|
11 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Injection Site Induration
|
22 Subjects
|
15 Subjects
|
34 Subjects
|
8 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Any Systemic
|
72 Subjects
|
79 Subjects
|
85 Subjects
|
23 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Chills
|
12 Subjects
|
10 Subjects
|
24 Subjects
|
6 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Nausea
|
15 Subjects
|
20 Subjects
|
22 Subjects
|
0 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Malaise
|
19 Subjects
|
14 Subjects
|
23 Subjects
|
7 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Myalgia
|
25 Subjects
|
25 Subjects
|
35 Subjects
|
5 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Arthralgia
|
13 Subjects
|
5 Subjects
|
12 Subjects
|
2 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Headache
|
60 Subjects
|
63 Subjects
|
62 Subjects
|
19 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Fever ≥ 38°C
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Any Other
|
44 Subjects
|
45 Subjects
|
40 Subjects
|
14 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Analgesic/Antipyretic Med Used
|
44 Subjects
|
45 Subjects
|
39 Subjects
|
14 Subjects
|
|
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
Stayed home Due to a reaction
|
2 Subjects
|
2 Subjects
|
6 Subjects
|
2 Subjects
|
Adverse Events
MenACWY-CRM(Ad+)
Serious events: 4 serious events
Other events: 123 other events
Deaths: 0 deaths
MenACWY-CRM(Ad-)
Serious events: 2 serious events
Other events: 126 other events
Deaths: 0 deaths
MenACWY-PS - Stage 1
Serious events: 5 serious events
Other events: 128 other events
Deaths: 0 deaths
MenACWY-PS -Stage 2
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY-CRM(Ad+)
n=164 participants at risk
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=151 participants at risk
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS - Stage 1
n=170 participants at risk
Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
|
MenACWY-PS -Stage 2
n=39 participants at risk
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
|
|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.61%
1/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.61%
1/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.59%
1/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.66%
1/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.59%
1/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
2.6%
1/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Infections and infestations
Cellulitis Pharyngeal
|
0.61%
1/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.59%
1/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Infections and infestations
Wound Infection
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.59%
1/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.61%
1/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.66%
1/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.59%
1/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.61%
1/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Nervous system disorders
Arachnoid Cyst
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.59%
1/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.00%
0/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
2.6%
1/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
Other adverse events
| Measure |
MenACWY-CRM(Ad+)
n=164 participants at risk
Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
|
MenACWY-CRM(Ad-)
n=151 participants at risk
Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
|
MenACWY-PS - Stage 1
n=170 participants at risk
Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
|
MenACWY-PS -Stage 2
n=39 participants at risk
Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.1%
15/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
14.6%
22/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
11.8%
20/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.00%
0/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
General disorders
Chills
|
7.3%
12/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
15.9%
24/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
5.9%
10/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
15.4%
6/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
General disorders
Injection Site Erythema
|
20.1%
33/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
37.7%
57/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
16.5%
28/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
28.2%
11/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
General disorders
Injection Site Induration
|
13.4%
22/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
22.5%
34/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
8.8%
15/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
20.5%
8/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
General disorders
Injection Site Pain
|
56.1%
92/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
53.6%
81/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
55.9%
95/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
48.7%
19/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
General disorders
Malaise
|
12.2%
20/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
15.2%
23/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
8.2%
14/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
17.9%
7/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Infections and infestations
Pharyngitis
|
3.7%
6/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
1.3%
2/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
2.4%
4/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
5.1%
2/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.2%
2/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
7.9%
12/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
0.59%
1/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
7.7%
3/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
13/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
7.9%
12/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
2.9%
5/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
5.1%
2/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.9%
26/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
23.2%
35/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
14.7%
25/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
12.8%
5/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
|
Nervous system disorders
Headache
|
36.6%
60/164 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
41.1%
62/151 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
37.1%
63/170 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
48.7%
19/39 • All solicited adverse events (AEs) were collected upto day 7 after each vaccination.
All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60