Trial Outcomes & Findings for Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination (NCT NCT01239043)
NCT ID: NCT01239043
Last Updated: 2012-06-25
Results Overview
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - \> 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
139 participants
Primary outcome timeframe
Day 0 to Day 7 post-vaccination
Results posted on
2012-06-25
Participant Flow
Participants were enrolled from 08 November 2010 to 16 December 2010 at 6 US clinical centers.
A total of 139 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Menomune® Vaccine Group
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
103
|
|
Overall Study
COMPLETED
|
34
|
102
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Menomune® Vaccine Group
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
Baseline characteristics by cohort
| Measure |
Menomune® Vaccine Group
n=36 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=103 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
Total
n=139 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age Continuous
|
71.8 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
71.1 Years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
71.3 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 7 post-vaccinationPopulation: Solicited reactions were assessed in all subjects who received at a dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - \> 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.
Outcome measures
| Measure |
Menomune® Vaccine Group
n=34 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=103 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Any Pain
|
8 Participants
|
33 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Grade 3 Pain
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Any Erythema
|
9 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Grade 3 Erythema
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Any Swelling
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Grade 3 Swelling
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Any Fever
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Grade 3 Fever
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Any Headache
|
8 Participants
|
16 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Grade 3 Headache
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Any Malaise
|
3 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Grade 3 Malaise
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Any Myalgia
|
6 Participants
|
22 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Grade 3 Myalgia
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Outcome measures
| Measure |
Menomune® Vaccine Group
n=32 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=99 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup W-135 Post-vaccination (N = 31, 99)
|
6.4 Titers
Interval 4.4 to 9.3
|
80.1 Titers
Interval 55.0 to 116.5
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup A Pre-vaccination (N = 32, 99)
|
7.2 Titers
Interval 4.4 to 11.8
|
10.1 Titers
Interval 7.6 to 13.3
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup A Post-vaccination (N = 31, 99)
|
15.6 Titers
Interval 9.2 to 26.5
|
87.1 Titers
Interval 62.0 to 122.3
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup C Pre-vaccination (N = 32, 99)
|
9.9 Titers
Interval 5.5 to 18.0
|
6.6 Titers
Interval 4.9 to 8.9
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup C Post-vaccination (N = 32, 99)
|
14.4 Titers
Interval 7.4 to 27.8
|
93.4 Titers
Interval 63.0 to 138.5
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup Y Pre-vaccination (N = 32, 99)
|
7.2 Titers
Interval 4.1 to 12.6
|
6.2 Titers
Interval 4.4 to 8.7
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup Y Post-vaccination (N = 31, 99)
|
11.4 Titers
Interval 6.2 to 21.1
|
96.1 Titers
Interval 62.1 to 148.5
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Serogroup W-135 Pre-vaccination (N = 32, 99)
|
4.1 Titers
Interval 2.9 to 5.7
|
7.6 Titers
Interval 5.6 to 10.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).
Outcome measures
| Measure |
Menomune® Vaccine Group
n=32 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=99 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup A ≥ 1:4 Pre-vaccination (N = 32, 99)
|
23 Participants
|
79 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup A ≥ 1:8 Post-vaccination (N = 31, 99)
|
24 Participants
|
92 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup C ≥1:4 Pre-vaccination (N = 32, 99)
|
20 Participants
|
55 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup C ≥ 1:8 Pre-vaccination (N = 32, 99)
|
17 Participants
|
41 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup C ≥1:4 Post-vaccination (N = 32, 99)
|
24 Participants
|
95 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup C ≥ 1:8 Post-vaccination (N = 32, 99)
|
18 Participants
|
90 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup Y ≥ 1:4 Pre-vaccination (N = 32, 99)
|
15 Participants
|
43 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup Y ≥ 1:8 Pre-vaccination (N = 32, 99)
|
14 Participants
|
34 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup A ≥ 1:8 Pre-vaccination (N = 32, 99)
|
14 Participants
|
57 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup A ≥ 1:4 Post-vaccination (N = 31, 99)
|
28 Participants
|
97 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup Y ≥1:4 Post-vaccination (N = 31, 99)
|
19 Participants
|
89 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup Y≥1:8 Post -vaccination (N = 31, 99)
|
18 Participants
|
87 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup W-135 ≥1:4 Pre-vaccination (N = 32, 99)
|
15 Participants
|
59 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup W-135 ≥1:8 Pre-vaccination (N = 32, 99)
|
12 Participants
|
44 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup W-135 ≥1:4 Post-accination (N = 31, 99)
|
25 Participants
|
95 Participants
Interval 0.0 to 0.0
|
|
Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Serogroup W-135 ≥1:8 Post-vaccination (N = 31, 99)
|
14 Participants
|
92 Participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Outcome measures
| Measure |
Menomune® Vaccine Group
n=32 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=99 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.
Serogroup A (N = 31, 99)
|
8 Participants
|
70 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.
Serogroup C (N = 32, 99)
|
5 Participants
|
77 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.
Serogroup Y (N = 31, 99)
|
4 Participants
|
75 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.
Serogroup W-135 (N = 31, 99)
|
2 Participants
|
73 Participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Menomune® Vaccine Group
n=32 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=99 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup A Pre-vaccination (N = 32, 99)
|
22.1 Titers
Interval 9.5 to 51.6
|
20.2 Titers
Interval 12.8 to 31.7
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup A Post -vccination (N = 31, 98)
|
119.7 Titers
Interval 45.9 to 312.3
|
396.9 Titers
Interval 266.8 to 590.5
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup C Pre-vaccination (N = 32, 99)
|
39.7 Titers
Interval 16.2 to 97.6
|
35 Titers
Interval 22.1 to 55.6
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup C Post-vaccination (N = 31, 98)
|
109.5 Titers
Interval 40.2 to 298.0
|
698.9 Titers
Interval 450.4 to 1084.7
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup Y Pre-vaccination (N = 32, 99)
|
71.3 Titers
Interval 36.1 to 140.9
|
70.6 Titers
Interval 46.6 to 106.8
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup Y Post-vaccination (N = 31, 99)
|
200.2 Titers
Interval 98.8 to 405.4
|
556.9 Titers
Interval 370.6 to 836.8
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup W-135 Pre-vaccination (N = 32, 99)
|
74.5 Titers
Interval 37.5 to 147.9
|
79 Titers
Interval 52.4 to 118.9
|
|
Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Serogroup W-135 Post-vaccination (N = 31, 98)
|
214.1 Titers
Interval 101.6 to 451.2
|
534.2 Titers
Interval 351.7 to 811.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine and serology samples with valid test results (Per-Protocol Population).
Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Menomune® Vaccine Group
n=32 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=99 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup A Pre-vaccination (N = 32, 99)
|
12 Participants
|
35 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup A Post-vaccination (N = 31, 98)
|
21 Participants
|
87 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup C Pre-vaccination (N = 32, 99)
|
17 Participants
|
53 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup C Post-vaccination (N = 31, 98)
|
20 Participants
|
91 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup Y Pre-vaccination (N = 32, 99)
|
26 Participants
|
75 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup Y Post-vaccination (N = 31, 99)
|
29 Participants
|
94 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup W-135 Pre-vaccination (N = 32, 99)
|
25 Participants
|
75 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Serogroup W-135 Post-vaccination (N = 31, 98)
|
27 Participants
|
91 Participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Menomune® Vaccine Group
n=31 Participants
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=99 Participants
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine
Serogroup A (N = 31, 98)
|
12 Participants
|
69 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine
Serogroup C (N = 31, 98)
|
10 Participants
|
78 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine
Serogroup Y (N = 31, 99)
|
17 Participants
|
60 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine
Serogroup W-135 (N = 31, 98)
|
13 Participants
|
67 Participants
Interval 0.0 to 0.0
|
Adverse Events
Menomune® Vaccine Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Menactra® Vaccine Group
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menomune® Vaccine Group
n=36 participants at risk
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
|
Menactra® Vaccine Group
n=103 participants at risk
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
|
|---|---|---|
|
General disorders
Injection Site Pain
|
23.5%
8/34 • Number of events 8 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
32.0%
33/103 • Number of events 33 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
|
General disorders
Injection Site Erythema
|
26.5%
9/34 • Number of events 9 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
0.00%
0/103 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
|
General disorders
Malaise
|
8.8%
3/34 • Number of events 3 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
7.8%
8/103 • Number of events 8 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.3%
3/36 • Number of events 3 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
0.97%
1/103 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
5.6%
2/36 • Number of events 2 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
0.00%
0/103 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
6/34 • Number of events 6 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
21.4%
22/103 • Number of events 22 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
|
Nervous system disorders
Headache
|
23.5%
8/34 • Number of events 8 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
15.5%
16/103 • Number of events 16 • Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER