Meningitis, Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, Meningococcal conjugate Vaccine, Menactra®
Brief summary
This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan. Primary Objective: * To describe the seroprotection rate \[% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128\] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age Secondary Objectives: * To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age * To describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.
Detailed description
All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity assessment and safety monitoring post-vaccination.
Interventions
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 2 through 55 years on the day of inclusion * For subjects ≥ 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent(s) or other legal representative. Also subjects 7 to 11 years of age will provide assent and subjects 12 to 19 years of age will provide written assent form. * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
Exclusion criteria
* Any acute and/or serious disease/illness that, in the opinion of the investigator, is 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 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 may 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 (HIV) infection * Ineligible according to the investigator's clinical judgment * Known pregnancy, or suspected pregnancy or a positive (serum and/or urine) pregnancy test * Currently breast feeding a child * 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 that might interfere with the ability to comply with trial procedures * 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 * History of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | 28 Days post-vaccination | Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | 28 Days post-vaccination | Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). |
| Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | 28 Days post-vaccination | Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). |
| Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Days 0 and 28 post-vaccination | Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). |
| Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | 28 Days post-vaccination | Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Day 0 up to Day 28 post-vaccination | Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities. |
Countries
Japan
Participant flow
Recruitment details
Study participants were enrolled from 20 January through 25 February 2012 in 4 clinic sites in Japan.
Pre-assignment details
A total of 200 subjects who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Adults Menactra® Vaccine Group Participants aged 18 to 55 years received a single dose of Menactra® vaccine | 194 |
| Adolescents Menactra® Vaccine Group Participants aged 11 to 17 years received a single dose of Menactra® vaccine | 2 |
| Children Menactra® Vaccine Group Participants aged 2 to 10 years received a single dose of Menactra® vaccine | 4 |
| Total | 200 |
Baseline characteristics
| Characteristic | Adolescents Menactra® Vaccine Group | Children Menactra® Vaccine Group | Adults Menactra® Vaccine Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 4 Participants | 0 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 194 Participants | 194 Participants |
| Age Continuous | 11.0 Years STANDARD_DEVIATION 0 | 4.3 Years STANDARD_DEVIATION 2.6 | 35.6 Years STANDARD_DEVIATION 11.2 | 34.7 Years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Japan | 2 Participants | 4 Participants | 194 Participants | 200 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 97 Participants | 99 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 97 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 63 / 194 | 2 / 2 | 4 / 4 |
| serious Total, serious adverse events | 0 / 194 | 0 / 2 | 0 / 4 |
Outcome results
Primary
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.
Time frame: 28 Days post-vaccination
Population: Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 194, 2, 4) | 177 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 193, 2, 4) | 172 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 192, 2, 4) | 154 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 192, 2, 4) | 180 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 193, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 194, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 192, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 192, 2, 4) | 2 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 192, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 193, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 192, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 194, 2, 4) | 4 Participants |
Secondary
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities.
Time frame: Day 0 up to Day 28 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Malaise | 30 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Swelling | 0 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Erythema | 5 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Headache | 0 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Fever | 3 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Pain | 0 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Headache | 22 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Fever | 0 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Malaise | 3 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Erythema | 0 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Myalgia | 1 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Pain | 60 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Swelling | 2 Participants |
| Adults Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Myalgia | 48 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Malaise | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Pain | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Pain | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Erythema | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Erythema | 1 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Swelling | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Swelling | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Fever | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Fever | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Headache | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Headache | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Malaise | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Myalgia | 0 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Myalgia | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Myalgia | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Headache | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Swelling | 3 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Erythema | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Malaise | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Erythema | 3 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any injection site Pain | 3 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Malaise | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Pain | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Fever | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Fever | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 Myalgia | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Any Headache | 0 Participants |
| Children Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine | Grade 3 injection site Swelling | 0 Participants |
Secondary
Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time frame: 28 Days post-vaccination
Population: Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup A (N = 193, 2, 4) | 150 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup C (N = 191, 2, 4) | 151 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup Y (N = 191, 2, 4) | 139 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup W-135 (N = 192, 2, 4) | 169 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup W-135 (N = 192, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup A (N = 193, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup Y (N = 191, 2, 4) | 1 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup C (N = 191, 2, 4) | 2 Participants |
| Children Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup W-135 (N = 192, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup C (N = 191, 2, 4) | 3 Participants |
| Children Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup Y (N = 191, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. | Serogroup A (N = 193, 2, 4) | 4 Participants |
Secondary
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time frame: 28 Days post-vaccination
Population: Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 194, 2, 4) | 180 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 192, 2, 4) | 167 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 192, 2, 4) | 190 Participants |
| Adults Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 193, 2, 4) | 186 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 193, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 194, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 192, 2, 4) | 2 Participants |
| Adolescents Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 192, 2, 4) | 2 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 193, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 192, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 192, 2, 4) | 4 Participants |
| Children Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 194, 2, 4) | 4 Participants |
Secondary
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time frame: 28 Days post-vaccination
Population: Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 193, 2, 4) | 31.9 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 191, 2, 4) | 40.8 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 191, 2, 4) | 16.1 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 192, 2, 4) | 53.6 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 192, 2, 4) | 64.0 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 193, 2, 4) | 724.1 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 191, 2, 4) | 4.0 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 191, 2, 4) | 512.0 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (N = 192, 2, 4) | 215.3 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (N = 191, 2, 4) | 53.8 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (N = 191, 2, 4) | 32.0 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (N = 193, 2, 4) | 4096.0 Titers |
Secondary
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time frame: Days 0 and 28 post-vaccination
Population: Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (Day 0; N = 193, 2, 4) | 26.0 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (Day 28; N = 194, 2, 4) | 1202.6 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (Day 0; N = 193, 2, 4) | 5.6 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (Day 28; N = 192, 2, 4) | 389.1 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (Day 0; N = 193, 2, 4) | 64.2 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (Day 28; N = 192, 2, 4) | 1244.4 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (Day 0; N = 193, 2, 4) | 12.8 Titers |
| Adults Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (Day 28; N = 193, 2, 4) | 995.0 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (Day 0; N = 193, 2, 4) | 2 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (Day 0; N = 193, 2, 4) | 128.0 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (Day 28; N = 192, 2, 4) | 2048.0 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (Day 0; N = 193, 2, 4) | 181.0 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (Day 28; N = 192, 2, 4) | 724.1 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (Day 0; N = 193, 2, 4) | 2.0 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (Day 28; N = 194, 2, 4) | 2896.3 Titers |
| Adolescents Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (Day 28; N = 193, 2, 4) | 8192.0 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (Day 0; N = 193, 2, 4) | 5.7 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (Day 28; N = 194, 2, 4) | 16384.0 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup A (Day 0; N = 193, 2, 4) | 2.0 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup C (Day 28; N = 192, 2, 4) | 512.0 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (Day 0; N = 193, 2, 4) | 38.1 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (Day 28; N = 192, 2, 4) | 3444.3 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup Y (Day 0; N = 193, 2, 4) | 107.6 Titers |
| Children Menactra® Vaccine Group | Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine | Serogroup W-135 (Day 28; N = 193, 2, 4) | 9742.0 Titers |