Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Meningococcal Vaccine, Menactra®, Menomune®
Brief summary
Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Immunogenicity: To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.
Interventions
BIOLOGICALMenomune®: A, C, Y, W-135 Meningococcal Polysaccharide
0.5 mL, Subcutaneous
BIOLOGICALMenactra®: Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ambulatory and healthy, as determined by medical history. * 56 years of age or older at the time of vaccination. * Signed Institutional Review Board (IRB)-approved informed consent form. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman, inability to become pregnant or a negative urine pregnancy test at the time of enrollment.
Exclusion criteria
* Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine. * Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc) that is unstable or that might 1) interfere with the ability to participate fully in the study or 2) interfere with evaluation of the vaccines. * Known or suspected impairment of immunologic function. * Febrile illness within the last 72 hours or an oral temperature ≥ 100.4ºF at the time of inclusion. * History of documented invasive meningococcal disease or previous meningococcal vaccination. * Known or suspected receipt of a diphtheria-containing vaccine within the preceding 2 years. * Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * Systemic antibiotic therapy within the 72 hours prior to collection of any blood samples. * Received any vaccine in the 28-day period prior to enrollment or scheduled to receive any vaccination through Visit 2 for Groups 1 and 2 and through Visit 3 for Groups 3 and 4. Influenza vaccines may be received 2 weeks before or after a study vaccination. * Suspected or known hypersensitivity to latex or to any of the components of either Menactra® vaccine or Menomune® vaccine. * Previous personal history of Guillain-Barré syndrome. * Not available for the entire study period or unable to attend the scheduled visits or to comply with the study procedures. * In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment. * A nursing mother. * Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study. * Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial visits or procedures. * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | 0-7 days post-vaccination 1 | Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting. |
| Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | 0-7 Days Post-vaccination 2 | Solicited injection site reactions: Pain, Erythema, and Swelling. |
| Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Day 0 to 7 Post-vaccination 2 | Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting. |
Other
| Measure | Time frame |
|---|---|
| Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Day 0 and 28 days Post-vaccination 2 |
| Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Day 28 Post-vaccination 1 |
| Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Day 0 and Day 28 Post-vaccination 2 |
| Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Day 28 Post-vaccination 1 |
| Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Day 28 Post-vaccination 2 |
| Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Day 0 and Day 28 Post-vaccination 1 |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled and treated from 10 October 2007 to 25 August 2008 at 6 US clinical centers.
Pre-assignment details
A total of 216 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Menomune® Day 0 Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0. | 51 |
| Group 2: Menactra® Day 0 x 2 Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0. | 56 |
| Group 3: Menactra® Day 0 and 14 Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14. | 51 |
| Group 4: Menactra® Day 0 and 28 Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28. | 58 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Group 2: Menactra® Day 0 x 2 | Group 3: Menactra® Day 0 and 14 | Group 1: Menomune® Day 0 | Group 4: Menactra® Day 0 and 28 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 32 Participants | 32 Participants | 40 Participants | 141 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 19 Participants | 18 Participants | 75 Participants |
| Age Continuous | 68.6 Years STANDARD_DEVIATION 7 | 68.5 Years STANDARD_DEVIATION 7.2 | 69.0 Years STANDARD_DEVIATION 7.2 | 69.1 Years STANDARD_DEVIATION 7.3 | 68.8 Years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 56 participants | 51 participants | 51 participants | 58 participants | 216 participants |
| Sex: Female, Male Female | 27 Participants | 34 Participants | 29 Participants | 34 Participants | 124 Participants |
| Sex: Female, Male Male | 29 Participants | 17 Participants | 22 Participants | 24 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 51 | 5 / 56 | 8 / 51 | 12 / 58 |
| serious Total, serious adverse events | 4 / 51 | 3 / 56 | 1 / 51 | 0 / 58 |
Outcome results
Primary
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Time frame: 0-7 days post-vaccination 1
Population: Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Diarrhea | 2 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Chills (Prevents daily activities) | 1 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Systemic Reaction | 20 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Vomiting | 1 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Chills | 4 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Arthralgia (Prevents daily activities) | 1 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Systemic Reaction | 3 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Arthralgia | 4 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Anorexia (Prevents daily activities) | 2 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Anorexia | 3 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Myalgia | 10 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Pain (Incapacitating) | 1 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Injection Site Reaction | 4 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Malaise (Prevents daily activities) | 1 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Injection Site Reaction | 26 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Erythema | 22 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Vomiting (Prevents daily activities) | 0 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Malaise | 6 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Erythema (≥ 5 cm) | 3 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Urticaria (Prevents daily activities) | 0 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Headache | 11 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Swelling | 10 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Urticaria | 1 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Fever | 3 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Diarrhea (Prevents daily activities) | 0 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 1: Menomune® Day 0 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Pain | 12 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Malaise | 6 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Injection Site Reaction | 20 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Injection Site Reaction | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Pain | 16 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Erythema | 5 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Swelling | 6 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Systemic Reaction | 23 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Systemic Reaction | 1 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Anorexia | 4 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Anorexia (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Arthralgia | 4 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Arthralgia (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Chills | 4 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Chills (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Diarrhea | 5 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Diarrhea (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Fever | 2 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Headache | 11 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Malaise (Prevents daily activities) | 1 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Myalgia | 13 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Urticaria | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Urticaria (Prevents daily activities) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Vomiting | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Vomiting (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Malaise | 5 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Swelling (≥ 5 cm) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Vomiting (Prevents daily activities) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Malaise (Prevents daily activities) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Urticaria (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Vomiting | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Myalgia | 11 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Injection Site Reaction | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Pain | 24 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Erythema (≥ 5 cm) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Anorexia | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Diarrhea (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Headache | 11 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Myalgia (Prevents daily activities) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Anorexia (Prevents daily activities) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Chills (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Systemic Reaction | 3 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Swelling | 5 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Arthralgia | 7 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Diarrhea | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Fever | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Arthralgia (Prevents daily activities) | 2 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Erythema | 9 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Systemic Reaction | 19 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Injection Site Reaction | 28 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Chills | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Urticaria | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Chills | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Chills (Prevents daily activities) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Urticaria | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Diarrhea | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Swelling | 3 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Diarrhea (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Vomiting (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Fever | 3 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Fever (> 102.2 ºF) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Urticaria (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Headache | 12 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Erythema | 8 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Injection Site Reaction | 23 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Pain (Incapacitating) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Malaise | 9 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Malaise (Prevents daily activities) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Pain | 18 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Myalgia | 10 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Vomiting | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Anorexia | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Systemic Reaction | 3 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Anorexia (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Arthralgia | 5 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Any Solicited Systemic Reaction | 23 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Solicited Injection Site Reaction | 3 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Arthralgia (Prevents daily activities) | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. | Grade 3 Swelling (≥ 5 cm) | 2 Participants |
Primary
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Solicited injection site reactions: Pain, Erythema, and Swelling.
Time frame: 0-7 Days Post-vaccination 2
Population: Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Solicited Injection site reaction | 17 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Swelling | 5 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Solicited Injection site reaction | 0 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Erythema | 7 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Pain | 14 Participants |
| Group 2: Menactra® Day 0 x 2 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Solicited Injection site reaction | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Swelling | 5 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Solicited Injection site reaction | 25 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Pain | 24 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Erythema | 5 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Swelling (≥ 5 cm) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Erythema (≥ 5 cm) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Solicited Injection site reaction | 24 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Solicited Injection site reaction | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Pain | 22 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Erythema | 6 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 | Any Swelling | 3 Participants |
Primary
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Time frame: Day 0 to 7 Post-vaccination 2
Population: Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Fever (> 102.2 ºF) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Chills | 4 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Headache | 9 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Anorexia | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Chills (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Malaise | 10 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Arthralgia | 5 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Diarrhea | 2 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Myalgia | 12 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Solicited Systemic Reaction | 3 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Diarrhea (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Urticaria | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Arthralgia (Prevents daily activities) | 1 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Urticaria (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Fever | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Vomiting | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Anorexia (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Vomiting (Prevents daily activities) | 0 Participants |
| Group 3: Menactra® Day 0 and 14 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Solicited Systemic Reaction | 19 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Vomiting (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Solicited Systemic Reaction | 13 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Solicited Systemic Reaction | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Anorexia | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Anorexia (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Arthralgia | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Arthralgia (Prevents daily activities) | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Chills | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Chills (Prevents daily activities) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Diarrhea | 3 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Diarrhea (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Fever | 3 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Fever (> 102.2 ºF) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Headache | 7 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Malaise | 3 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Malaise (Prevents daily activities) | 1 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Myalgia | 7 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Urticaria | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Grade 3 Urticaria (Prevents daily activities) | 0 Participants |
| Group 4: Menactra® Day 0 and 28 | Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 | Any Vomiting | 0 Participants |
Other Pre-specified
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Time frame: Day 0 and Day 28 Post-vaccination 1
Population: Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Pre-dose 1 | 21.1 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Pre-dose 1 | 9.9 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Pre-dose 1 | 27.4 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Pre-dose 1 | 13.3 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Post-dose 1 | 3870.7 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Post-dose 1 | 927.5 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Post-dose 1 | 750.1 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Post-dose 1 | 782.7 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Pre-dose 1 | 28.9 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Post-dose 1 | 141.7 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Pre-dose 1 | 10.3 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Post-dose 1 | 2048.0 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Post-dose 1 | 529.6 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Pre-dose 1 | 18.6 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Pre-dose 1 | 16.6 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Post-dose 1 | 78.4 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Pre-dose 1 | 14.9 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Pre-dose 1 | 7.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Pre-dose 1 | 19.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Pre-dose 1 | 11.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Post-dose 1 | 143.7 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Post-dose 1 | 367.3 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Post-dose 1 | 1874.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Post-dose 1 | 221.6 Titers |
Other Pre-specified
Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Time frame: Day 0 and 28 days Post-vaccination 2
Population: Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 16.8 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 11.0 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Pre-dose 1 | 22.6 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 12.9 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 3168.6 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 568.5 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 311.5 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 276.9 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Pre-dose 1 | 28.9 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 264.8 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 10.3 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 2871.9 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 1041.5 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 18.6 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 16.6 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 212.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Pre-dose 1 | 14.9 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 7.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 19.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 11.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 259.7 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 574.7 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 2543.3 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 566.5 Titers |
Post Hoc
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Time frame: Day 0 and Day 28 Post-vaccination 1
Population: Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Pre-dose 1 | 4.6 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Pre-dose 1 | 3.9 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Pre-dose 1 | 5.2 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Pre-dose 1 | 2.8 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Post-dose 1 | 14.3 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Post-dose 1 | 15.1 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Post-dose 1 | 23.8 Titers |
| Group 1: Menomune® Day 0 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Post-dose 1 | 13.5 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Pre-dose 1 | 3.4 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Post-dose 1 | 6.8 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Pre-dose 1 | 2.8 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Post-dose 1 | 40.5 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Post-dose 1 | 18.9 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Pre-dose 1 | 4.3 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Pre-dose 1 | 3.1 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Post-dose 1 | 7.1 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Pre-dose 1 | 3.3 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Pre-dose 1 | 3.4 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Pre-dose 1 | 4.1 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Pre-dose 1 | 3.1 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y, Post-dose 1 | 10.4 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup C, Post-dose 1 | 14.9 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup A, Post-dose 1 | 22.6 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135, Post-dose 1 | 12.5 Titers |
Post Hoc
Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Time frame: Day 0 and Day 28 Post-vaccination 2
Population: Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 4.9 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 3.9 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y Pre-dose 1 | 5.4 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 4.3 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 47.6 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 25.7 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 28.1 Titers |
| Group 2: Menactra® Day 0 x 2 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 26.1 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y Pre-dose 1 | 3.4 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 10.1 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 2.8 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 48.0 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 17.7 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 4.3 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 3.1 Titers |
| Group 3: Menactra® Day 0 and 14 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 9.3 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y Pre-dose 1 | 3.3 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 3.4 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 4.1 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 3.1 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 12.7 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 18.8 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 21.1 Titers |
| Group 4: Menactra® Day 0 and 28 | Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 18.2 Titers |
Other Pre-specified
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Time frame: Day 28 Post-vaccination 1
Population: Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup A ≥ 1:8 Pre-Dose 1 | 38 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup C ≥ 1:8 Pre-Dose 1 | 25 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y ≥1:8 Pre-Dose 1 | 55 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135 ≥ 1:8 Pre-Dose 1 | 35 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup A ≥ 1:8 Post-Dose 1 | 100 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup C ≥ 1:8 Post-Dose 1 | 88 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y ≥ 1:8 Post-Dose 1 | 96 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135 ≥ 1:8 Post-Dose 1 | 94 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y ≥1:8 Pre-Dose 1 | 54 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y ≥ 1:8 Post-Dose 1 | 78 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135 ≥ 1:8 Pre-Dose 1 | 29 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup A ≥ 1:8 Post-Dose 1 | 95 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup C ≥ 1:8 Post-Dose 1 | 78 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup A ≥ 1:8 Pre-Dose 1 | 34 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup C ≥ 1:8 Pre-Dose 1 | 34 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135 ≥ 1:8 Post-Dose 1 | 68 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y ≥1:8 Pre-Dose 1 | 38 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup C ≥ 1:8 Pre-Dose 1 | 19 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup A ≥ 1:8 Pre-Dose 1 | 35 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135 ≥ 1:8 Pre-Dose 1 | 33 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup Y ≥ 1:8 Post-Dose 1 | 71 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup C ≥ 1:8 Post-Dose 1 | 79 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup A ≥ 1:8 Post-Dose 1 | 98 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 | Meningococcal Serogroup W-135 ≥ 1:8 Post-Dose 1 | 90 Percentage of Participants |
Other Pre-specified
Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Time frame: Day 0 and Day 28 Post-vaccination 2
Population: Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, ≥ 1:8 Pre-dose 1 | 28 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, ≥ 1:8 Pre-dose 1 | 24 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, ≥ 1:8 Pre-dose 1 | 54 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, ≥ 1:8 Pre-dose 1 | 30 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, ≥ 1:8 Post-dose 2 | 98 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, ≥ 1:8 Post-dose 2 | 79 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, ≥ 1:8 Post-dose 2 | 93 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, ≥ 1:8 Post-dose 2 | 83 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, ≥ 1:8 Pre-dose 1 | 54 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, ≥ 1:8 Post-dose 2 | 90 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, ≥ 1:8 Pre-dose 1 | 29 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, ≥ 1:8 Post-dose 2 | 100 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, ≥ 1:8 Post-dose 2 | 90 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, ≥ 1:8 Pre-dose 1 | 34 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, ≥ 1:8 Pre-dose 1 | 34 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, ≥ 1:8 Post-dose 2 | 81 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, ≥ 1:8 Pre-dose 1 | 38 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, ≥ 1:8 Pre-dose 1 | 19 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, ≥ 1:8 Pre-dose 1 | 35 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, ≥ 1:8 Pre-dose 1 | 33 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, ≥ 1:8 Post-dose 2 | 85 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, ≥ 1:8 Post-dose 2 | 83 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, ≥ 1:8 Post-dose 2 | 100 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, ≥ 1:8 Post-dose 2 | 94 Percentage of Participants |
Post Hoc
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Time frame: Day 28 Post-vaccination 1
Population: Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup A, Pre-dose 1 | 39 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup C, Pre-dose 1 | 22 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup Y, Pre-dose 1 | 31 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup W-135, Pre-dose 1 | 16 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup A, Post-dose 1 | 63 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup C, Post-dose 1 | 57 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup Y, Post-dose 1 | 63 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup W-135, Post-dose 1 | 63 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup Y, Pre-dose 1 | 17 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup Y, Post-dose 1 | 37 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup W-135, Pre-dose 1 | 12 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup A, Post-dose 1 | 76 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup C, Post-dose 1 | 56 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup A, Pre-dose 1 | 32 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup C, Pre-dose 1 | 15 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup W-135, Post-dose 1 | 46 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup Y, Pre-dose 1 | 17 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup C, Pre-dose 1 | 19 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup A, Pre-dose 1 | 27 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup W-135, Pre-dose 1 | 19 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup Y, Post-dose 1 | 44 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup C, Post-dose 1 | 52 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup A, Post-dose 1 | 73 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1. | Meningococcal Serogroup W-135, Post-dose 1 | 50 Percentage of Participants |
Post Hoc
Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Time frame: Day 0 and 28 days post-vaccination
Population: Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 65 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 26 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 63 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 82 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 72 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 22 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Pre-dose 1 | 37 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 33 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 15 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 32 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Pre-dose 1 | 17 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 12 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 81 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 56 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 54 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 56 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Pre-dose 1 | 19 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup C, Post-dose 2 | 65 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Pre-dose 1 | 27 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Post-dose 2 | 63 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup W-135, Pre-dose 1 | 19 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Post-dose 2 | 54 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup A, Post-dose 2 | 75 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2 | Meningococcal Serogroup Y, Pre-dose 1 | 17 Percentage of Participants |
Other Pre-specified
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.
Time frame: Day 28 Post-vaccination 1
Population: Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup A | 90 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup C | 86 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup Y | 84 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup W-135 | 92 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup W-135 | 51 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup A | 88 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup Y | 56 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup C | 68 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup W-135 | 73 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup C | 75 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup Y | 54 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. | Meningococcal Serogroup A | 89 Percentage of Participants |
Other Pre-specified
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2
Time frame: Day 28 Post-vaccination 2
Population: Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup A | 91 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup C | 72 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup Y | 66 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup W-135 | 72 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup W-135 | 73 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup A | 90 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup Y | 76 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup C | 85 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup W-135 | 81 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup C | 83 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup Y | 73 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 | Meningococcal Serogroup A | 98 Percentage of Participants |
Post Hoc
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1
Time frame: Day 28 Post-vaccination 1
Population: Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup A | 37 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup C | 31 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup Y | 49 Percentage of Participants |
| Group 1: Menomune® Day 0 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup W-135 | 47 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup W-135 | 20 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup A | 63 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup Y | 20 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup C | 44 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup W-135 | 33 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup C | 35 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup Y | 29 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1 | Meningococcal Serogroup A | 44 Percentage of Participants |
Post Hoc
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2
Time frame: 28 Days post-vaccination 2
Population: Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup A | 65 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup C | 48 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup Y | 48 Percentage of Participants |
| Group 2: Menactra® Day 0 x 2 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup W-135 | 44 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup W-135 | 27 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup A | 68 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup Y | 29 Percentage of Participants |
| Group 3: Menactra® Day 0 and 14 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup C | 44 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup W-135 | 46 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup C | 48 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup Y | 40 Percentage of Participants |
| Group 4: Menactra® Day 0 and 28 | Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2 | Meningococcal Serogroup A | 44 Percentage of Participants |