Meningitis, Meningococcal Disease
Conditions
Keywords
Meningitis, Meningococcal disease, Menactra®, Adacel®
Brief summary
The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in support of registration of the vaccine in South Korea. Primary Objective: * To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y and W-135, 28 days after a single dose of Menactra®. Secondary objectives: * To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine * To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine. * To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers before and 28 days after a single dose of Menactra® or Adacel® vaccine.
Detailed description
All participants will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination. Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day 28 post-vaccination.
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 11 to 55 years on the day of inclusion * Subject aged 11 to 19 years: assent form signed and dated by the subject and informed consent form signed and dated by at least 1 parent or another legal representative * Subject aged 20 to 55 years: informed consent form signed and dated by the subject If the subject or the subject's parent(s) or legal representative is illiterate, an independent witness is required to sign the consent form. * Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and comply with all trial procedures * Covered by health insurance.
Exclusion criteria
* Subject is pregnant, or lactating, or of child-bearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post menopausal for at least 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or using an effective method of contraception or abstinence for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination) * Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure * Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the trial vaccination. Monovalent pandemic influenza vaccines and multivalent pandemic influenza vaccines can be administered at any time during the study * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine * Vaccination against diphtheria or tetanus in the past 5 years or any previous vaccination with either Adacel® or any other Tdap vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of invasive meningococcal disease, confirmed either clinically, serologically, or microbiologically * At high risk for invasive meningococcal disease during the trial * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * Thrombocytopenia, bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided * Received oral or injectable antibiotic therapy within the 72 hours prior to the first blood draw * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study * Personal history of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | 28 Days post-vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Day 0 (pre-vaccination) and 28 days post-vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution. |
| Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Day 0 (pre-vaccination) and 28 days post-vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution. |
| Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Day 0 (pre-vaccination) and 28 days post-vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). |
| Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Day 0 up to Day 28 post-vaccination | Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - \> 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity. |
Countries
South Korea
Participant flow
Recruitment details
The study participants were enrolled from 13 July 2012 to 17 December 2012 in 8 clinic centers in South Korea.
Pre-assignment details
A total of 300 participants that met all inclusion but none of the exclusion criteria were randomized and vaccinated in this study
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Group Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) | 200 |
| Tdap - Adacel® Group Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®) | 100 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Tdap - Adacel® Group | Menactra® Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 49 Participants | 100 Participants | 149 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 100 Participants | 151 Participants |
| Age Continuous | 24.2 Years STANDARD_DEVIATION 10.1 | 24.9 Years STANDARD_DEVIATION 11.5 | 24.7 Years STANDARD_DEVIATION 11 |
| Region of Enrollment Korea, Republic of | 100 Participants | 200 Participants | 300 Participants |
| Sex: Female, Male Female | 58 Participants | 107 Participants | 165 Participants |
| Sex: Female, Male Male | 42 Participants | 93 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 200 | 76 / 100 |
| serious Total, serious adverse events | 0 / 200 | 0 / 100 |
Outcome results
Primary
Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.
Time frame: 28 Days post-vaccination
Population: Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup Y | 75 Percentage of participants |
| Menactra® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup W-135 | 92 Percentage of participants |
| Menactra® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup A | 78 Percentage of participants |
| Menactra® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup C | 88 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup C | 8 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup Y | 12 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup A | 9 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Serogroup W-135 | 8 Percentage of participants |
Secondary
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).
Time frame: Day 0 (pre-vaccination) and 28 days post-vaccination
Population: Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup Y (pre-vaccination) | 50.1 Titers |
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup C (pre-vaccination) | 5.80 Titers |
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup Y (post-vaccination) | 620 Titers |
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup A (pre-vaccination) | 46.1 Titers |
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (pre-vaccination) | 13.0 Titers |
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup C (post-vaccination) | 667 Titers |
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (post-vaccination) | 851 Titers |
| Menactra® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup A (post-vaccination) | 1121 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (post-vaccination) | 14.9 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup A (pre-vaccination) | 75.6 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup C (pre-vaccination) | 4.63 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup C (post-vaccination) | 5.64 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup Y (pre-vaccination) | 47.2 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup Y (post-vaccination) | 66.8 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (pre-vaccination) | 11.9 Titers |
| Tdap - Adacel® Group | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Serogroup A (post-vaccination) | 87.6 Titers |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - \> 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity.
Time frame: Day 0 up to Day 28 post-vaccination
Population: Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Injection Site Pain (199, 99) | 64 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Injection Site Pain (199, 99) | 1 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Injection Site Erythema (199, 99) | 5 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Injection Site Erythema (199, 99) | 0 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Injection Site Swelling (199, 99) | 3 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Injection Site Swelling (199, 99) | 0 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Fever (199, 99) | 0 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Fever (199, 99) | 0 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Headache (199, 99) | 37 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Headache (199, 99) | 2 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Malaise (199, 99) | 36 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Malaise (199, 99) | 1 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Myalgia (199, 99) | 51 Participants |
| Menactra® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Myalgia (199, 99) | 1 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Malaise (199, 99) | 23 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Injection Site Pain (199, 99) | 72 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Fever (199, 99) | 0 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Injection Site Pain (199, 99) | 2 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Myalgia (199, 99) | 42 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Injection Site Erythema (199, 99) | 9 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Headache (199, 99) | 24 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Injection Site Erythema (199, 99) | 0 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Malaise (199, 99) | 1 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Injection Site Swelling (199, 99) | 6 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Headache (199, 99) | 1 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Injection Site Swelling (199, 99) | 0 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Grade 3 Myalgia (199, 99) | 1 Participants |
| Tdap - Adacel® Group | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Fever (199, 99) | 3 Participants |
Secondary
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.
Time frame: Day 0 (pre-vaccination) and 28 days post-vaccination
Population: Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup A (Pre-vaccination) | 57 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup A (Post-vaccination) | 99 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup C (Pre-vaccination) | 25 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup C (Post-vaccination) | 89 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup Y (Pre-vaccination) | 52 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup Y (Post-vaccination) | 96 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup W 135 (Pre-vaccination) | 22 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup W 135 (Post-vaccination) | 95 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup W 135 (Post-vaccination) | 27 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup A (Pre-vaccination) | 64 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup Y (Pre-vaccination) | 48 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup A (Post-vaccination) | 70 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup W 135 (Pre-vaccination) | 25 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup C (Pre-vaccination) | 15 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup Y (Post-vaccination) | 57 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Serogroup C (Post-vaccination) | 16 Percentage of participants |
Secondary
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.
Time frame: Day 0 (pre-vaccination) and 28 days post-vaccination
Population: Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup Y (Pre vaccination) | 75 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup A (Post-vaccination) | 100 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup Y (Post-vaccination) | 99 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup A (Pre-vaccination) | 68 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (Pre-vaccination) | 50 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup C (Pre-vaccination) | 28 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (Post-vaccination) | 98 Percentage of participants |
| Menactra® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup C (Post-vaccination) | 93 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (Post-vaccination) | 48 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup A (Pre-vaccination) | 76 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup A (Post-vaccination) | 78 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup C (Post-vaccination) | 24 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup Y (Pre vaccination) | 75 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup Y (Post-vaccination) | 81 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup W-135 (Pre-vaccination) | 44 Percentage of participants |
| Tdap - Adacel® Group | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Serogroup C (Pre-vaccination) | 19 Percentage of participants |