Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1174-4291 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants.
Primary Objective:
Other Pre-specified objective:
All participants received a 2-dose series of the study vaccine with 8-week interval and was monitored for safety and assessed for immunogenicity at baseline (pre-vaccination) and at 28 to 35 days following each vaccination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Vaccine | Experimental | Participants received 2-dose series of the study vaccine with 8-week interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular (2 doses with 8-week interval) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR). | Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following 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. | Day 28 post-vaccination 1, Day 28 post-vaccination 2 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | 532-0003 | Japan |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 60 participants were enrolled in the study.
Participants were enrolled from 20 October 2015 through 18 December 2015 at a single center in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Vaccine | Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | 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. | Within 7 days post-vaccination 1, Within 7 days post-vaccination 2 |
| Vaccinated Dose 1 |
|
| Vaccinated Dose 2 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Vaccine | Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR). | 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. | Posted | Count of Participants | Participants | Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following 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. | 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. | Posted | Count of Participants | Participants | Day 28 post-vaccination 1, Day 28 post-vaccination 2 |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | 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. | Safety analysis set included all participants who received at least 1 dose of study vaccine. | Posted | Count of Participants | Participants | Within 7 days post-vaccination 1, Within 7 days post-vaccination 2 |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Menactra® Vaccine | Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval. | 0 | 60 | 0 | 60 | 32 | 60 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 18.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Serogroup C (Pre-Vaccination) |
|
| Serogroup C (Day 28 post-vaccination 1) |
|
| Serogroup C (Day 28 post-vaccination 2) |
|
| Serogroup Y (Pre-Vaccination) |
|
| Serogroup Y (Day 28 post-vaccination 1) |
|
| Serogroup Y (Day 28 post-vaccination 2) |
|
| Serogroup W-135 (Pre-Vaccination) |
|
| Serogroup W-135 (Day 28 post-vaccination 1) |
|
| Serogroup W-135 (Day 28 post-vaccination 2) |
|
|
|