Trial Outcomes & Findings for Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects (NCT NCT02591290)
NCT ID: NCT02591290
Last Updated: 2017-11-06
Results Overview
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2
Results posted on
2017-11-06
Participant Flow
Participants were enrolled from 20 October 2015 through 18 December 2015 at a single center in Japan.
A total of 60 participants were enrolled in the study.
Participant milestones
| Measure |
Menactra® Vaccine
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Vaccinated Dose 1
|
60
|
|
Overall Study
Vaccinated Dose 2
|
58
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Menactra® Vaccine
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Menactra® Vaccine
n=60 Participants
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
|
|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2Population: Per Protocol (PP) analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).
Outcome measures
| Measure |
Menactra® Vaccine
n=56 Participants
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
|
|---|---|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup A (Pre-Vaccination)
|
43 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup A (Day 28 post-vaccination 1)
|
56 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup A (Day 28 post-vaccination 2)
|
56 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup C (Pre-Vaccination)
|
15 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup C (Day 28 post-vaccination 1)
|
47 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup C (Day 28 post-vaccination 2)
|
52 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup Y (Pre-Vaccination)
|
28 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup Y (Day 28 post-vaccination 1)
|
54 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup Y (Day 28 post-vaccination 2)
|
53 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup W-135 (Pre-Vaccination)
|
15 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup W-135 (Day 28 post-vaccination 1)
|
51 Participants
|
|
Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Serogroup W-135 (Day 28 post-vaccination 2)
|
53 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-vaccination 1, Day 28 post-vaccination 2Population: PP analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR in the serum specimens. Number of participants with \>=4-fold rise in each meningococcal serogroups antibody titer at Day 28 post-vaccination 1 and at Day 28 post-vaccination 2 were reported.
Outcome measures
| Measure |
Menactra® Vaccine
n=56 Participants
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
|
|---|---|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup A (Day 28 post-vaccination 1)
|
40 Participants
|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup A (Day 28 post-vaccination 2)
|
39 Participants
|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup C (Day 28 post-vaccination 1)
|
46 Participants
|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup C (Day 28 post-vaccination 2)
|
47 Participants
|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup W-135 (Day 28 post-vaccination 2)
|
55 Participants
|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup W-135 (Day 28 post-vaccination 1)
|
52 Participants
|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup Y (Day 28 post-vaccination 1)
|
43 Participants
|
|
Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Serogroup Y (Day 28 post-vaccination 2)
|
48 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2Population: Safety analysis set included all participants who received at least 1 dose of study vaccine.
Solicited injection (Inj.) site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference), erythema and swelling (Grade 1: \>=25 to \<=50 mm; Grade 2: \>=51 to \<=100 mm; Grade 3: \>100 mm); Solicited systemic reactions: Fever (Grade 1: \>=37.5 degree Celsius to \<=38.4 degree Celsius, Grade 2: \>=38.5 degree Celsius to \<=38.9 degree Celsius, Grade 3: \>=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.
Outcome measures
| Measure |
Menactra® Vaccine
n=60 Participants
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
|
|---|---|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Inj site pain (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Erythema (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Myalgia (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Inj. site pain (post-vaccination 1)
|
18 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Inj site pain (post-vaccination 2)
|
17 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Inj site pain (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Erythema (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Erythema (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Erythema (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Swelling (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Swelling (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Swelling (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Swelling (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Fever (post-vaccination 1)
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Fever (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Fever (post-vaccination 2)
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Fever (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Headache (post-vaccination 1)
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Headache (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Headache (post-vaccination 2)
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Headache (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Malaise (post-vaccination 1)
|
9 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Malaise (post-vaccination 1)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Malaise (post-vaccination 2)
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Malaise (post-vaccination 2)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Myalgia (post-vaccination 1)
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Any Myalgia (post-vaccination 2)
|
11 Participants
|
|
Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Grade 3 Myalgia (post-vaccination 2)
|
0 Participants
|
Adverse Events
Menactra® Vaccine
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menactra® Vaccine
n=60 participants at risk
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
|
|---|---|
|
Nervous system disorders
Headache
|
11.7%
7/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 98 days at the longest.
A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.0%
18/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 98 days at the longest.
A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Injection site pain
|
41.7%
25/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 98 days at the longest.
A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Malaise
|
16.7%
10/60 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 98 days at the longest.
A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset 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