Measles, Meningococcal Meningitis, Mumps, Rubella, Varicella
Conditions
Keywords
Menactra vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella virus, Haemophilus influenzae type b, Pneumococcal conjugate vaccine
Brief summary
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age. Primary Objective: To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135. Secondary Objectives: Immunogenicity * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines. * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine. Safety \- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.
Interventions
BIOLOGICALMeningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
249 Days to 305 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy, as determined by medical history and physical examination. * Aged 9 months (249 to 291 days) at the time of enrollment. * The parent or legal guardian has signed and dated the Institutional Review Board-approved informed consent form
Exclusion criteria
* Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion. * Known or suspected impairment of immunologic function. * Acute medical illness within the last 72 hours, or temperature ≥ 100.4 ºF (≥ 38.0 ºC) at the time of enrollment. * History of documented invasive meningococcal disease or previous meningococcal vaccination. * Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian * Received either immune globulin or other blood products within the last 3 months, or received injected or oral corticosteroids, or other immunomodulator therapy within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 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. Topical steroids are not included in this exclusion criterion. * Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion. * Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin. * Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination. * Parent or legal guardian unable or unwilling to comply with the study procedures. * Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period. * Diagnosed with any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their 4th dose of Pneumococcal Conjugate (PCV) or Hib vaccine or their first dose of Measles-Mumps-Rubella-Varicella (MMRV) vaccine before enrollment. * Personal or family history of Guillain-Barré Syndrome (GBS). * History of seizures, including febrile seizures, or any other neurologic disorder. * Known hypersensitivity to dry natural rubber latex (pertinent to the Menactra® vaccine needle shield)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | 30 days post-visit 2 Menactra® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | 0-7 days post-vaccination | Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination. |
Other
| Measure | Time frame |
|---|---|
| Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | 30 days post-Visit 2 Menactra® |
| Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | 30 days post-Visit 2 Menactra® |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 20 September 2006 to 29 September 2007 at 71 US clinical centers.
Pre-assignment details
A total of 1118 participants were enrolled, vaccinated, and included in data analysis.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Menactra® Vaccine Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 407 |
| Group 2: Menactra® + MMRV Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months. | 293 |
| Group 3: Menactra® + PCV Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months. | 418 |
| Total | 1,118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 11 | 13 | 3 |
| Overall Study | Protocol Violation | 7 | 15 | 13 |
| Overall Study | Withdrawal by Subject | 14 | 17 | 15 |
Baseline characteristics
| Characteristic | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV | Group 1: Menactra® Vaccine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 293 Participants | 418 Participants | 407 Participants | 1118 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 279.8 Days STANDARD_DEVIATION 10.93 | 279.5 Days STANDARD_DEVIATION 11.11 | 278.7 Days STANDARD_DEVIATION 10.55 | 279.3 Days STANDARD_DEVIATION 10.86 |
| Region of Enrollment United States | 293 participants | 418 participants | 407 participants | 1118 participants |
| Sex: Female, Male Female | 128 Participants | 217 Participants | 217 Participants | 562 Participants |
| Sex: Female, Male Male | 165 Participants | 201 Participants | 190 Participants | 556 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 210 / 407 | 137 / 293 | 222 / 418 |
| serious Total, serious adverse events | 16 / 407 | 9 / 293 | 17 / 418 |
Outcome results
Primary
Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Time frame: 30 days post-visit 2 Menactra®
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup A | 96 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup C | 100 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup Y | 96 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup W-135 | 86 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup W-135 | 88 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup A | 93 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup Y | 97 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup C | 99 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup W-135 | 81 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup C | 98 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup Y | 95 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup A | 91 Percentage of Participants |
Secondary
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.
Time frame: 0-7 days post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Appetite Lost | 25 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - MMRV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness | 32 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) - MMRV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction Post-Dose 1 | 41 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Drowsiness | 31 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - PCV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction Post-Dose 2 | 43 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Gr 3 Tenderness (Cries when limb moved) PCV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 2 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Crying Abnormal | 34 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - PCV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - PCV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - Menactra Site | 36 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Vomiting | 16 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - PCV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema | 22 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Crying Abnormal | 35 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Fever (Any Route) | 13 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Systemic Reaction Post-Dose 1 | 68 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Irritability (Inconsolable) | 3 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - Menactra Site | 23 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Appetite Lost | 26 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Vomiting | 7 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - Menactra Site | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - Menactra Site | 10 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Irritability | 52 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Fever (Any Route) | 16 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) - Menactra Site | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Systemic Reaction Post-Dose 2 | 64 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - MMRV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling | 11 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Irritability (Inconsolable) | 2 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Gr 3 Tenderness (Cries when limb moved) MMRV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Irritability | 55 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - MMRV Site | 0 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Drowsiness | 28 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 1 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - MMRV Site | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Crying Abnormal (> 3 hours) | 1 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction Post-Dose 1 | 48 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness | 35 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema | 25 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) | 1 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling | 15 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) | 2 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction Post-Dose 2 | 49 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - Menactra Site | 39 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - Menactra Site | 26 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - Menactra Site | 2 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - Menactra Site | 14 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) - Menactra Site | 3 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - MMRV Site | 37 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Gr 3 Tenderness (Cries when limb moved) MMRV Site | 1 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - MMRV Site | 23 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - MMRV Site | 3 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - MMRV Site | 12 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) - MMRV Site | 2 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - PCV Site | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Gr 3 Tenderness (Cries when limb moved) PCV Site | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - PCV Site | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - PCV Site | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - PCV Site | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Systemic Reaction Post-Dose 1 | 64 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Fever (Any Route) | 12 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) | 2 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Vomiting | 14 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Crying Abnormal | 36 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Drowsiness | 30 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Appetite Lost | 26 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 0 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Irritability | 57 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Irritability (Inconsolable) | 2 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Systemic Reaction Post-Dose 2 | 74 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Fever (Any Route) | 26 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) | 4 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Vomiting | 10 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 1 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Crying Abnormal | 39 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Drowsiness | 32 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Appetite Lost | 32 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 2 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Irritability | 61 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Irritability (Inconsolable) | 3 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Drowsiness (Sleeps most of time) | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - MMRV Site | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Drowsiness | 33 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Appetite Lost | 27 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - MMRV Site | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) | 2 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Gr 3 Tenderness (Cries when limb moved) MMRV Site | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Irritability (Inconsolable) | 5 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Irritability | 53 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - MMRV Site | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Irritability (Inconsolable) | 2 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) - Menactra Site | 2 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema | 22 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Systemic Reaction Post-Dose 2 | 68 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - Menactra Site | 17 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Irritability | 57 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Fever (Any Route) | 22 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - Menactra Site | 3 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Appetite Lost | 32 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) | 1 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - Menactra Site | 27 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Vomiting | 11 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction Post-Dose 1 | 43 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Systemic Reaction Post-Dose 1 | 67 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) | 3 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - Menactra Site | 48 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Fever (Any Route) | 13 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - PCV Site | 20 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 2 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) | 2 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Erythema (≥ 2.0 in) - PCV Site | 4 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Crying Abnormal | 38 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Vomiting | 15 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Erythema - PCV Site | 30 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction Post-Dose 2 | 54 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Gr 3 Tenderness (Cries when limb moved) PCV Site | 1 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) | 1 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Crying Abnormal | 33 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness - PCV Site | 47 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Crying Abnormal (> 3 hours) | 5 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Crying Abnormal (> 3 hours) | 1 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Grade 3 Swelling (≥ 2.0 in) - MMRV Site | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling | 11 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Drowsiness | 30 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Swelling - MMRV Site | 0 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination | Any Tenderness | 32 Percentage of Participants |
Other Pre-specified
Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.
Time frame: 30 days post-Visit 2 Menactra®
Population: Geometric mean titers and their 95% Confidence Intervals, measured by SBA-HC, were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Menactra® Vaccine | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup Y | 52.4 Titers |
| Group 1: Menactra® Vaccine | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup A | 54.9 Titers |
| Group 1: Menactra® Vaccine | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup W-135 | 24.3 Titers |
| Group 1: Menactra® Vaccine | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup C | 141.8 Titers |
| Group 2: Menactra® + MMRV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup Y | 60.2 Titers |
| Group 2: Menactra® + MMRV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup C | 161.9 Titers |
| Group 2: Menactra® + MMRV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup A | 52 Titers |
| Group 2: Menactra® + MMRV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup W-135 | 27.9 Titers |
| Group 3: Menactra® + PCV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup C | 109.5 Titers |
| Group 3: Menactra® + PCV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup A | 41 Titers |
| Group 3: Menactra® + PCV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup W-135 | 17.9 Titers |
| Group 3: Menactra® + PCV | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. | Meningococcal Serogroup Y | 39.9 Titers |
Other Pre-specified
Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Time frame: 30 days post-Visit 2 Menactra®
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup A | 98 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup C | 100 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup Y | 99 Percentage of Participants |
| Group 1: Menactra® Vaccine | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup W-135 | 93 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup W-135 | 96 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup A | 98 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup Y | 99 Percentage of Participants |
| Group 2: Menactra® + MMRV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup C | 100 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup W-135 | 91 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup C | 99 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup Y | 98 Percentage of Participants |
| Group 3: Menactra® + PCV | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) | Meningococcal Serogroup A | 97 Percentage of Participants |