Trial Outcomes & Findings for Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea (NCT NCT01642589)
NCT ID: NCT01642589
Last Updated: 2013-12-03
Results Overview
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
28 Days post-vaccination
Results posted on
2013-12-03
Participant Flow
The study participants were enrolled from 13 July 2012 to 17 December 2012 in 8 clinic centers in South Korea.
A total of 300 participants that met all inclusion but none of the exclusion criteria were randomized and vaccinated in this study
Participant milestones
| Measure |
Menactra® Group
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
100
|
|
Overall Study
COMPLETED
|
199
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Menactra® Group
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea
Baseline characteristics by cohort
| Measure |
Menactra® Group
n=200 Participants
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
n=100 Participants
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.9 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
24.2 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
24.7 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
200 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 Days post-vaccinationPopulation: Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.
Outcome measures
| Measure |
Menactra® Group
n=200 Participants
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
n=100 Participants
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
Serogroup A
|
78 Percentage of participants
|
9 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
Serogroup C
|
88 Percentage of participants
|
8 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
Serogroup Y
|
75 Percentage of participants
|
12 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
Serogroup W-135
|
92 Percentage of participants
|
8 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and 28 days post-vaccinationPopulation: Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.
Outcome measures
| Measure |
Menactra® Group
n=200 Participants
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
n=100 Participants
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup A (Pre-vaccination)
|
68 Percentage of participants
|
76 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup A (Post-vaccination)
|
100 Percentage of participants
|
78 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup C (Pre-vaccination)
|
28 Percentage of participants
|
19 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup C (Post-vaccination)
|
93 Percentage of participants
|
24 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup Y (Pre vaccination)
|
75 Percentage of participants
|
75 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup Y (Post-vaccination)
|
99 Percentage of participants
|
81 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup W-135 (Pre-vaccination)
|
50 Percentage of participants
|
44 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Serogroup W-135 (Post-vaccination)
|
98 Percentage of participants
|
48 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and 28 days post-vaccinationPopulation: Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.
Outcome measures
| Measure |
Menactra® Group
n=200 Participants
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
n=100 Participants
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup A (Pre-vaccination)
|
57 Percentage of participants
|
64 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup A (Post-vaccination)
|
99 Percentage of participants
|
70 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup C (Pre-vaccination)
|
25 Percentage of participants
|
15 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup C (Post-vaccination)
|
89 Percentage of participants
|
16 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup Y (Pre-vaccination)
|
52 Percentage of participants
|
48 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup Y (Post-vaccination)
|
96 Percentage of participants
|
57 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup W 135 (Pre-vaccination)
|
22 Percentage of participants
|
25 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Serogroup W 135 (Post-vaccination)
|
95 Percentage of participants
|
27 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and 28 days post-vaccinationPopulation: Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).
Outcome measures
| Measure |
Menactra® Group
n=200 Participants
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
n=100 Participants
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup A (pre-vaccination)
|
46.1 Titers
Interval 33.7 to 63.2
|
75.6 Titers
Interval 48.9 to 117.0
|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup A (post-vaccination)
|
1121 Titers
Interval 949.0 to 1324.0
|
87.6 Titers
Interval 57.1 to 135.0
|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup C (pre-vaccination)
|
5.80 Titers
Interval 4.5 to 7.46
|
4.63 Titers
Interval 3.26 to 6.56
|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup C (post-vaccination)
|
667 Titers
Interval 504.0 to 884.0
|
5.64 Titers
Interval 3.82 to 8.32
|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup Y (pre-vaccination)
|
50.1 Titers
Interval 37.7 to 66.6
|
47.2 Titers
Interval 31.9 to 69.8
|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup Y (post-vaccination)
|
620 Titers
Interval 521.0 to 738.0
|
66.8 Titers
Interval 45.5 to 98.0
|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup W-135 (pre-vaccination)
|
13.0 Titers
Interval 9.83 to 17.1
|
11.9 Titers
Interval 7.79 to 18.1
|
|
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Serogroup W-135 (post-vaccination)
|
851 Titers
Interval 690.0 to 1050.0
|
14.9 Titers
Interval 9.5 to 23.4
|
SECONDARY outcome
Timeframe: Day 0 up to Day 28 post-vaccinationPopulation: Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - \> 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity.
Outcome measures
| Measure |
Menactra® Group
n=200 Participants
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
n=100 Participants
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Injection Site Pain (199, 99)
|
64 Participants
|
72 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Grade 3 Injection Site Pain (199, 99)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Injection Site Erythema (199, 99)
|
5 Participants
|
9 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Grade 3 Injection Site Erythema (199, 99)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Injection Site Swelling (199, 99)
|
3 Participants
|
6 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Grade 3 Injection Site Swelling (199, 99)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Fever (199, 99)
|
0 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Grade 3 Fever (199, 99)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Headache (199, 99)
|
37 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Grade 3 Headache (199, 99)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Malaise (199, 99)
|
36 Participants
|
23 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Grade 3 Malaise (199, 99)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Myalgia (199, 99)
|
51 Participants
|
42 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Grade 3 Myalgia (199, 99)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
Adverse Events
Menactra® Group
Serious events: 0 serious events
Other events: 92 other events
Deaths: 0 deaths
Tdap - Adacel® Group
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menactra® Group
n=200 participants at risk
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
|
Tdap - Adacel® Group
n=100 participants at risk
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
|
|---|---|---|
|
General disorders
Injection Site Pain
|
32.2%
64/199 • Number of events 64 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
72.7%
72/99 • Number of events 72 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
|
General disorders
Injection Site Erythema
|
2.5%
5/199 • Number of events 5 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
9.1%
9/99 • Number of events 9 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
|
General disorders
Injection Site Swelling
|
1.5%
3/199 • Number of events 3 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
6.1%
6/99 • Number of events 6 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
|
Nervous system disorders
Headache
|
18.6%
37/199 • Number of events 37 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
24.2%
24/99 • Number of events 24 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
|
General disorders
Malaise
|
18.1%
36/199 • Number of events 36 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
23.2%
23/99 • Number of events 23 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.6%
51/199 • Number of events 51 • Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
|
42.4%
42/99 • Number of events 42 • Adverse events data were collected from Day 0 (post-vaccination) up to 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