Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT02591290|
Recruitment Status : Completed
First Posted : October 29, 2015
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants.
- To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C, Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20 through 55 years of age.
Other Pre-specified objective:
- To describe the safety in terms of immediate systemic adverse events (AEs), solicited reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs) following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.
|Condition or disease||Intervention/treatment||Phase|
|Meningitis Meningococcal Meningitis Meningococcal Infections||Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of Two-Dose Series of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284; Menactra®) in Japanese Healthy Adult Subjects|
|Actual Study Start Date :||October 20, 2015|
|Actual Primary Completion Date :||March 16, 2016|
|Actual Study Completion Date :||March 16, 2016|
Experimental: Menactra® Vaccine
Participants received 2-dose series of the study vaccine with 8-week interval.
Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular (2 doses with 8-week interval)
- Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 [ Time Frame: Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2 ]Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).
- Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination [ Time Frame: Day 28 post-vaccination 1, Day 28 post-vaccination 2 ]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.
- Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination [ Time Frame: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591290
|Osaka, Japan, 532-0003|
|Study Director:||Medical Director||Sanofi KK|