Trial Outcomes & Findings for Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years (NCT NCT00874549)
NCT ID: NCT00874549
Last Updated: 2013-09-20
Results Overview
Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
216 participants
Primary outcome timeframe
0-7 days post-vaccination 1
Results posted on
2013-09-20
Participant Flow
Participants were enrolled and treated from 10 October 2007 to 25 August 2008 at 6 US clinical centers.
A total of 216 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in the analyses.
Participant milestones
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
56
|
51
|
58
|
|
Overall Study
COMPLETED
|
50
|
55
|
47
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
2
|
Reasons for withdrawal
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years
Baseline characteristics by cohort
| Measure |
Group 1: Menomune® Day 0
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=56 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=58 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Age Continuous
|
69.0 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
68.6 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
68.5 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
69.1 Years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
68.8 Years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
56 participants
n=7 Participants
|
51 participants
n=5 Participants
|
58 participants
n=4 Participants
|
216 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0-7 days post-vaccination 1Population: Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.
Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=56 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=58 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Solicited Injection Site Reaction
|
26 Participants
|
20 Participants
|
28 Participants
|
23 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Solicited Injection Site Reaction
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Pain
|
12 Participants
|
16 Participants
|
24 Participants
|
18 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Pain (Incapacitating)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Erythema
|
22 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Erythema (≥ 5 cm)
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Swelling
|
10 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Swelling (≥ 5 cm)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Solicited Systemic Reaction
|
20 Participants
|
23 Participants
|
19 Participants
|
23 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Solicited Systemic Reaction
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Anorexia
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Anorexia (Prevents daily activities)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Arthralgia
|
4 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Arthralgia (Prevents daily activities)
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Chills
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Malaise (Prevents daily activities)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Chills (Prevents daily activities)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Diarrhea
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Diarrhea (Prevents daily activities)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Fever
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Fever (> 102.2 ºF)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Headache
|
11 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Myalgia
|
10 Participants
|
13 Participants
|
11 Participants
|
10 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Myalgia (Prevents daily activities)
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Urticaria
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Urticaria (Prevents daily activities)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Vomiting
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Vomiting (Prevents daily activities)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Grade 3 Headache (Prevents daily activities)
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Any Malaise
|
6 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 0-7 Days Post-vaccination 2Population: Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.
Solicited injection site reactions: Pain, Erythema, and Swelling.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=56 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=58 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Any Solicited Injection site reaction
|
—
|
17 Participants
|
25 Participants
|
24 Participants
|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Grade 3 Solicited Injection site reaction
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Any Pain
|
—
|
14 Participants
|
24 Participants
|
22 Participants
|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Grade 3 Pain (Incapacitating)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Any Erythema
|
—
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Grade 3 Erythema (≥ 5 cm)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Any Swelling
|
—
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Grade 3 Swelling (≥ 5 cm)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 7 Post-vaccination 2Population: Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.
Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=58 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Solicited Systemic Reaction
|
—
|
—
|
19 Participants
|
13 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Solicited Systemic Reaction
|
—
|
—
|
3 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Anorexia
|
—
|
—
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Anorexia (Prevents daily activities)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Arthralgia
|
—
|
—
|
5 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Arthralgia (Prevents daily activities)
|
—
|
—
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Chills
|
—
|
—
|
4 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Chills (Prevents daily activities)
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Diarrhea
|
—
|
—
|
2 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Diarrhea (Prevents daily activities)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Fever
|
—
|
—
|
0 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Fever (> 102.2 ºF)
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Headache
|
—
|
—
|
9 Participants
|
7 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Headache (Prevents daily activities)
|
—
|
—
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Malaise
|
—
|
—
|
10 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Malaise (Prevents daily activities)
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Myalgia
|
—
|
—
|
12 Participants
|
7 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Myalgia (Prevents daily activities)
|
—
|
—
|
0 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Urticaria
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Urticaria (Prevents daily activities)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Any Vomiting
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Grade 3 Vomiting (Prevents daily activities)
|
—
|
—
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 Post-vaccination 1Population: Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
n=49 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.
Meningococcal Serogroup A
|
90 Percentage of Participants
|
—
|
88 Percentage of Participants
|
89 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.
Meningococcal Serogroup C
|
86 Percentage of Participants
|
—
|
68 Percentage of Participants
|
75 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.
Meningococcal Serogroup Y
|
84 Percentage of Participants
|
—
|
56 Percentage of Participants
|
54 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.
Meningococcal Serogroup W-135
|
92 Percentage of Participants
|
—
|
51 Percentage of Participants
|
73 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 Post-vaccination 2Population: Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=54 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=58 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2
Meningococcal Serogroup C
|
—
|
72 Percentage of Participants
|
85 Percentage of Participants
|
83 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2
Meningococcal Serogroup A
|
—
|
91 Percentage of Participants
|
90 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2
Meningococcal Serogroup Y
|
—
|
66 Percentage of Participants
|
76 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2
Meningococcal Serogroup W-135
|
—
|
72 Percentage of Participants
|
73 Percentage of Participants
|
81 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 and Day 28 Post-vaccination 1Population: Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
n=49 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup A, Pre-dose 1
|
21.1 Titers
Interval 11.0 to 40.5
|
—
|
18.6 Titers
Interval 9.1 to 38.1
|
19.6 Titers
Interval 10.0 to 38.3
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup C, Pre-dose 1
|
9.9 Titers
Interval 6.1 to 16.1
|
—
|
16.6 Titers
Interval 8.5 to 32.2
|
7.6 Titers
Interval 4.9 to 11.6
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup Y, Pre-dose 1
|
27.4 Titers
Interval 15.1 to 49.8
|
—
|
28.9 Titers
Interval 14.9 to 56.0
|
14.9 Titers
Interval 8.6 to 25.8
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup W-135, Pre-dose 1
|
13.3 Titers
Interval 8.0 to 22.0
|
—
|
10.3 Titers
Interval 6.1 to 17.3
|
11.6 Titers
Interval 7.1 to 19.2
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup A, Post-dose 1
|
3870.7 Titers
Interval 2611.0 to 5738.0
|
—
|
2048.0 Titers
Interval 1082.2 to 3875.7
|
1874.6 Titers
Interval 1199.7 to 2929.1
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup C, Post-dose 1
|
927.5 Titers
Interval 433.6 to 1983.8
|
—
|
529.6 Titers
Interval 204.6 to 1370.9
|
367.3 Titers
Interval 155.6 to 867.1
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup Y, Post-dose 1
|
750.1 Titers
Interval 434.8 to 1294.1
|
—
|
141.7 Titers
Interval 63.5 to 316.3
|
143.7 Titers
Interval 64.9 to 318.1
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Meningococcal Serogroup W-135, Post-dose 1
|
782.7 Titers
Interval 404.5 to 1514.4
|
—
|
78.4 Titers
Interval 35.5 to 173.1
|
221.6 Titers
Interval 117.4 to 418.1
|
POST_HOC outcome
Timeframe: Day 28 Post-vaccination 1Population: Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
n=49 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1
Meningococcal Serogroup A
|
37 Percentage of Participants
|
—
|
63 Percentage of Participants
|
44 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1
Meningococcal Serogroup C
|
31 Percentage of Participants
|
—
|
44 Percentage of Participants
|
35 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1
Meningococcal Serogroup Y
|
49 Percentage of Participants
|
—
|
20 Percentage of Participants
|
29 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1
Meningococcal Serogroup W-135
|
47 Percentage of Participants
|
—
|
20 Percentage of Participants
|
33 Percentage of Participants
|
POST_HOC outcome
Timeframe: 28 Days post-vaccination 2Population: Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=54 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2
Meningococcal Serogroup A
|
—
|
65 Percentage of Participants
|
68 Percentage of Participants
|
44 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2
Meningococcal Serogroup C
|
—
|
48 Percentage of Participants
|
44 Percentage of Participants
|
48 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2
Meningococcal Serogroup Y
|
—
|
48 Percentage of Participants
|
29 Percentage of Participants
|
40 Percentage of Participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2
Meningococcal Serogroup W-135
|
—
|
44 Percentage of Participants
|
27 Percentage of Participants
|
46 Percentage of Participants
|
POST_HOC outcome
Timeframe: Day 0 and Day 28 Post-vaccination 1Population: Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
n=49 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup A, Pre-dose 1
|
4.6 Titers
Interval 3.5 to 6.0
|
—
|
4.3 Titers
Interval 3.3 to 5.6
|
4.1 Titers
Interval 3.1 to 5.3
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup C, Pre-dose 1
|
3.9 Titers
Interval 2.9 to 5.4
|
—
|
3.1 Titers
Interval 2.3 to 4.2
|
3.4 Titers
Interval 2.6 to 4.5
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup Y, Pre-dose 1
|
5.2 Titers
Interval 3.4 to 7.9
|
—
|
3.4 Titers
Interval 2.3 to 4.9
|
3.3 Titers
Interval 2.4 to 4.4
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup W-135, Pre-dose 1
|
2.8 Titers
Interval 2.3 to 3.4
|
—
|
2.8 Titers
Interval 2.3 to 3.4
|
3.1 Titers
Interval 2.4 to 4.0
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup A, Post-dose 1
|
14.3 Titers
Interval 8.8 to 23.1
|
—
|
40.5 Titers
Interval 20.3 to 80.8
|
22.6 Titers
Interval 13.0 to 39.4
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup C, Post-dose 1
|
15.1 Titers
Interval 8.2 to 27.8
|
—
|
18.9 Titers
Interval 9.2 to 38.9
|
14.9 Titers
Interval 7.7 to 28.8
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup Y, Post-dose 1
|
23.8 Titers
Interval 12.8 to 44.2
|
—
|
6.8 Titers
Interval 4.0 to 11.4
|
10.4 Titers
Interval 5.9 to 18.3
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Meningococcal Serogroup W-135, Post-dose 1
|
13.5 Titers
Interval 8.6 to 21.1
|
—
|
7.1 Titers
Interval 4.3 to 11.8
|
12.5 Titers
Interval 6.7 to 23.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 and 28 days Post-vaccination 2Population: Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=54 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, Pre-dose 1
|
—
|
16.8 Titers
Interval 8.7 to 32.5
|
18.6 Titers
Interval 9.1 to 38.1
|
19.6 Titers
Interval 10.0 to 38.3
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, Pre-dose 1
|
—
|
11.0 Titers
Interval 6.5 to 18.6
|
16.6 Titers
Interval 8.5 to 32.2
|
7.6 Titers
Interval 4.9 to 11.6
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y, Pre-dose 1
|
—
|
22.6 Titers
Interval 14.2 to 36.1
|
28.9 Titers
Interval 14.9 to 56.0
|
14.9 Titers
Interval 8.6 to 25.8
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, Pre-dose 1
|
—
|
12.9 Titers
Interval 7.4 to 22.2
|
10.3 Titers
Interval 6.1 to 17.3
|
11.6 Titers
Interval 7.1 to 19.2
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, Post-dose 2
|
—
|
3168.6 Titers
Interval 2056.7 to 4881.7
|
2871.9 Titers
Interval 1823.9 to 4522.1
|
2543.3 Titers
Interval 1791.8 to 3610.0
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, Post-dose 2
|
—
|
568.5 Titers
Interval 240.0 to 1346.2
|
1041.5 Titers
Interval 492.4 to 2202.9
|
574.7 Titers
Interval 251.7 to 1312.1
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y, Post-dose 2
|
—
|
311.5 Titers
Interval 173.4 to 559.5
|
264.8 Titers
Interval 135.7 to 516.9
|
259.7 Titers
Interval 128.0 to 527.0
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, Post-dose 2
|
—
|
276.9 Titers
Interval 135.1 to 567.4
|
212.6 Titers
Interval 96.3 to 469.2
|
566.5 Titers
Interval 299.3 to 1071.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 Post-vaccination 1Population: Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
n=49 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup A ≥ 1:8 Pre-Dose 1
|
38 Percentage of Participants
|
—
|
34 Percentage of Participants
|
35 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup C ≥ 1:8 Pre-Dose 1
|
25 Percentage of Participants
|
—
|
34 Percentage of Participants
|
19 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup Y ≥1:8 Pre-Dose 1
|
55 Percentage of Participants
|
—
|
54 Percentage of Participants
|
38 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup W-135 ≥ 1:8 Pre-Dose 1
|
35 Percentage of Participants
|
—
|
29 Percentage of Participants
|
33 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup A ≥ 1:8 Post-Dose 1
|
100 Percentage of Participants
|
—
|
95 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup C ≥ 1:8 Post-Dose 1
|
88 Percentage of Participants
|
—
|
78 Percentage of Participants
|
79 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup Y ≥ 1:8 Post-Dose 1
|
96 Percentage of Participants
|
—
|
78 Percentage of Participants
|
71 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Meningococcal Serogroup W-135 ≥ 1:8 Post-Dose 1
|
94 Percentage of Participants
|
—
|
68 Percentage of Participants
|
90 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 and Day 28 Post-vaccination 2Population: Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=54 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y, ≥ 1:8 Post-dose 2
|
—
|
93 Percentage of Participants
|
90 Percentage of Participants
|
85 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, ≥ 1:8 Post-dose 2
|
—
|
83 Percentage of Participants
|
81 Percentage of Participants
|
94 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, ≥ 1:8 Pre-dose 1
|
—
|
28 Percentage of Participants
|
34 Percentage of Participants
|
35 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, ≥ 1:8 Pre-dose 1
|
—
|
24 Percentage of Participants
|
34 Percentage of Participants
|
19 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y, ≥ 1:8 Pre-dose 1
|
—
|
54 Percentage of Participants
|
54 Percentage of Participants
|
38 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, ≥ 1:8 Pre-dose 1
|
—
|
30 Percentage of Participants
|
29 Percentage of Participants
|
33 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, ≥ 1:8 Post-dose 2
|
—
|
98 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, ≥ 1:8 Post-dose 2
|
—
|
79 Percentage of Participants
|
90 Percentage of Participants
|
83 Percentage of Participants
|
POST_HOC outcome
Timeframe: Day 0 and Day 28 Post-vaccination 2Population: Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=56 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=51 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=58 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, Pre-dose 1
|
—
|
4.9 Titers
Interval 3.5 to 6.9
|
4.3 Titers
Interval 3.3 to 5.6
|
4.1 Titers
Interval 3.1 to 5.3
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, Pre-dose 1
|
—
|
3.9 Titers
Interval 2.9 to 5.3
|
3.1 Titers
Interval 2.3 to 4.2
|
3.4 Titers
Interval 2.6 to 4.5
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y Pre-dose 1
|
—
|
5.4 Titers
Interval 3.8 to 7.7
|
3.4 Titers
Interval 2.3 to 4.2
|
3.3 Titers
Interval 2.4 to 4.4
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, Pre-dose 1
|
—
|
4.3 Titers
Interval 3.1 to 5.8
|
2.8 Titers
Interval 2.3 to 3.4
|
3.1 Titers
Interval 2.4 to 4.0
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, Post-dose 2
|
—
|
47.6 Titers
Interval 26.9 to 84.2
|
48.0 Titers
Interval 27.4 to 84.2
|
21.1 Titers
Interval 12.6 to 35.0
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, Post-dose 2
|
—
|
25.7 Titers
Interval 13.8 to 47.9
|
17.7 Titers
Interval 8.9 to 35.3
|
18.8 Titers
Interval 9.9 to 35.6
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y, Post-dose 2
|
—
|
28.1 Titers
Interval 16.0 to 49.6
|
10.1 Titers
Interval 5.7 to 18.0
|
12.7 Titers
Interval 7.3 to 22.1
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, Post-dose 2
|
—
|
26.1 Titers
Interval 14.0 to 48.5
|
9.3 Titers
Interval 5.5 to 15.7
|
18.2 Titers
Interval 10.3 to 32.3
|
POST_HOC outcome
Timeframe: Day 28 Post-vaccination 1Population: Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
n=49 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup A, Pre-dose 1
|
39 Percentage of Participants
|
—
|
32 Percentage of Participants
|
27 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup C, Pre-dose 1
|
22 Percentage of Participants
|
—
|
15 Percentage of Participants
|
19 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup Y, Pre-dose 1
|
31 Percentage of Participants
|
—
|
17 Percentage of Participants
|
17 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup W-135, Pre-dose 1
|
16 Percentage of Participants
|
—
|
12 Percentage of Participants
|
19 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup A, Post-dose 1
|
63 Percentage of Participants
|
—
|
76 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup C, Post-dose 1
|
57 Percentage of Participants
|
—
|
56 Percentage of Participants
|
52 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup Y, Post-dose 1
|
63 Percentage of Participants
|
—
|
37 Percentage of Participants
|
44 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Meningococcal Serogroup W-135, Post-dose 1
|
63 Percentage of Participants
|
—
|
46 Percentage of Participants
|
50 Percentage of Participants
|
POST_HOC outcome
Timeframe: Day 0 and 28 days post-vaccinationPopulation: Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
Outcome measures
| Measure |
Group 1: Menomune® Day 0
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
|
Group 2: Menactra® Day 0 x 2
n=54 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
|
Group 3: Menactra® Day 0 and 14
n=41 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
|
Group 4: Menactra® Day 0 and 28
n=48 Participants
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, Pre-dose 1
|
—
|
33 Percentage of Participants
|
32 Percentage of Participants
|
27 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, Pre-dose 1
|
—
|
22 Percentage of Participants
|
15 Percentage of Participants
|
19 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y, Pre-dose 1
|
—
|
37 Percentage of Participants
|
17 Percentage of Participants
|
17 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, Pre-dose 1
|
—
|
26 Percentage of Participants
|
12 Percentage of Participants
|
19 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup A, Post-dose 2
|
—
|
82 Percentage of Participants
|
81 Percentage of Participants
|
75 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup C, Post-dose 2
|
—
|
65 Percentage of Participants
|
56 Percentage of Participants
|
65 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup Y, Post-dose 2
|
—
|
72 Percentage of Participants
|
54 Percentage of Participants
|
54 Percentage of Participants
|
|
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Meningococcal Serogroup W-135, Post-dose 2
|
—
|
63 Percentage of Participants
|
56 Percentage of Participants
|
63 Percentage of Participants
|
Adverse Events
Menomune® Day 0
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Menactra® Day 0 x 2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Menactra® Day 0 and Day 14
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Menactra® Day 0 and Day 28
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menomune® Day 0
n=51 participants at risk
|
Menactra® Day 0 x 2
n=56 participants at risk
|
Menactra® Day 0 and Day 14
n=51 participants at risk
|
Menactra® Day 0 and Day 28
n=58 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Syncope
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/56 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Vascular disorders
Femoral artery occlusion
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/56 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Vascular disorders
Transient ischaemic attack
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/56 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/56 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/56 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Endocrine disorders
Diabetes mellitus non-insulin-dependent
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
1.8%
1/56 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
1.8%
1/56 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
1.8%
1/56 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/58 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
Other adverse events
| Measure |
Menomune® Day 0
n=51 participants at risk
|
Menactra® Day 0 x 2
n=56 participants at risk
|
Menactra® Day 0 and Day 14
n=51 participants at risk
|
Menactra® Day 0 and Day 28
n=58 participants at risk
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
1.8%
1/56 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
9.8%
5/51 • Number of events 5 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
8.6%
5/58 • Number of events 5 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51 • Number of events 2 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
1.8%
1/56 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
3.9%
2/51 • Number of events 2 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
6.9%
4/58 • Number of events 5 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
5.4%
3/56 • Number of events 4 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
3.9%
2/51 • Number of events 2 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
1.7%
1/58 • Number of events 1 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/56 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
0.00%
0/51 • Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
|
5.2%
3/58 • Number of events 3 • Adverse events data were collected from day of enrollment to 6 Months after the last 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