Meningitis, Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine
Brief summary
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: * 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.
Detailed description
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.
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular (2 doses with 8-week interval)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 20 through 55 years on the day of inclusion, * Informed consent form had been signed and dated by the participant, * Able to attend all scheduled visits and to comply with all trial procedures, * For female participants who had childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination * a) 20 through 55 years meant from the day of the 20th birthday to the day before the 56th birthday. * b) To be considered to be not of childbearing potential, a woman must either had undergone surgical sterilization (hysterectomy or bilateral tubal ligation) or be postmenopausal (at least one year without menses) at the time of vaccination. Effective methods of contraception include oral contraception (pill), intrauterine device, diaphragm or condoms used with sponge, contraceptive foam or cream, hormonal implants, transdermal patch, or parenteral contraception.
Exclusion criteria
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion, * History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically, * Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine, * Known or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months), * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion, * Planned participation in another clinical trial during the present trial period, * Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response, * Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which might be received at least two weeks before the study vaccine, * Planned receipt of any vaccine during the trial period, * Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus infection, * Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination), * Known thrombocytopenia, contraindicating intramuscular (IM) vaccination, * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination, * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily, * Current alcohol abuse or drug addiction, * Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator, * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine, * At high risk for meningococcal infection during the trial, * Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination. A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided, * Received oral or injected antibiotic therapy within the 72 hours prior to blood draw (Visit 1), * History of Guillain-Barré Syndrome (GBS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination | 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 | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants were enrolled from 20 October 2015 through 18 December 2015 at a single center in Japan.
Pre-assignment details
A total of 60 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Vaccine Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Menactra® Vaccine |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment Japan | 60 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 32 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
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).
Time frame: Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menactra® Vaccine | Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 | Serogroup A (Pre-Vaccination) | 43 Participants |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 | Serogroup C (Pre-Vaccination) | 15 Participants |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 | Serogroup Y (Pre-Vaccination) | 28 Participants |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128 | Serogroup W-135 (Pre-Vaccination) | 15 Participants |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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
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.
Time frame: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
Population: Safety analysis set included all participants who received at least 1 dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Inj. site pain (post-vaccination 1) | 18 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Inj site pain (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Inj site pain (post-vaccination 2) | 17 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Inj site pain (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Erythema (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Erythema (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Erythema (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Erythema (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Swelling (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Swelling (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Swelling (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Fever (post-vaccination 2) | 1 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Myalgia (post-vaccination 2) | 11 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Myalgia (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Swelling (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Fever (post-vaccination 1) | 1 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Fever (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Fever (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Headache (post-vaccination 1) | 5 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Headache (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Headache (post-vaccination 2) | 5 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Headache (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Malaise (post-vaccination 1) | 9 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Malaise (post-vaccination 1) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Malaise (post-vaccination 2) | 3 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Malaise (post-vaccination 2) | 0 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Any Myalgia (post-vaccination 1) | 12 Participants |
| Menactra® Vaccine | Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination | Grade 3 Myalgia (post-vaccination 1) | 0 Participants |
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.
Time frame: Day 28 post-vaccination 1, Day 28 post-vaccination 2
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |
| Menactra® Vaccine | 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 |