Measles, Meningococcal Meningitis, Mumps, Rubella, Varicella
Conditions
Keywords
Menactra vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella vaccines, Haemophilus influenzae type b, Pneumococcal conjugate vaccine
Brief summary
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: * To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. * To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine. Observational Objectives: Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination\[s\]) in subjects in the study groups. Immunogenicity: \- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.
Detailed description
No meningococcal vaccine is presently licensed for the population aged \< 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged \< 2 years would address this important, currently unmet public health need. At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial. Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group
Interventions
BIOLOGICALMeningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, intramuscular (IM)
BIOLOGICALMeasles, Mumps, Rubella and Varicella
0.5 mL dose, SC
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
: * Healthy, as determined by medical history and physical examination * Aged 9 months (249 to 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment * The parent or legal guardian has signed and dated the Institutional Review Board (IRB)-approved informed consent form.
Exclusion criteria
: * Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, 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 a temperature ≥ 100.4ºF (≥38.0ºC) 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 any blood draw. Topical antibiotics and 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 planned 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 the study vaccines, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccines. 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 fourth dose of Pneumococcal conjugate vaccine (PCV) or Haemophilus influenzae type b (Hib) vaccine or their first dose of Measles, mumps, rubella, varicella (MMRV) vaccine before enrollment or been scheduled to receive these vaccines outside of the study-specified visits. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Day 30 after the 12-month vaccination | Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella. |
| Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Day 30 after the 12-month vaccination | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Day 30 after 12-month vaccination | — |
| Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Days 0 to 7 after vaccination | Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling. Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability. |
| Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Days 0 to 7 after vaccination | — |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled from 15 January 2007 to 16 March 2008 in 92 clinical centers in the US.
Pre-assignment details
A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented. 625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Menactra® at 9 and 12 Months Participants who received only Menactra® vaccination at 9 and 12 months of age | 257 |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age | 664 |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age | 246 |
| Group 4: MMRV + PCV at 12 Months Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age | 476 |
| Total | 1,643 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 12 | 6 | 6 |
| Overall Study | Protocol Violation | 4 | 25 | 8 | 5 |
| Overall Study | Serious adverse events | 1 | 4 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 25 | 7 | 13 |
Baseline characteristics
| Characteristic | Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Group 1: Menactra® at 9 and 12 Months | Group 4: MMRV + PCV at 12 Months | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 664 Participants | 246 Participants | 257 Participants | 476 Participants | 1643 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 283.0 Days STANDARD_DEVIATION 11.3 | 282.8 Days STANDARD_DEVIATION 10.3 | 283.4 Days STANDARD_DEVIATION 11.3 | 374.8 Days STANDARD_DEVIATION 8.6 | 283.4 Days STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 664 participants | 246 participants | 257 participants | 476 participants | 1643 participants |
| Sex: Female, Male Female | 349 Participants | 118 Participants | 119 Participants | 231 Participants | 817 Participants |
| Sex: Female, Male Male | 315 Participants | 128 Participants | 138 Participants | 245 Participants | 826 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 | 91 / 257 | 185 / 664 | 77 / 246 | 148 / 476 |
| serious Total, serious adverse events | 14 / 257 | 24 / 616 | 10 / 246 | 17 / 476 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4
Time frame: Day 30 after the 12-month vaccination
Population: Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 9V | 2.06 Titers |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 18C | 1.58 Titers |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 6B | 5.40 Titers |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 19F | 2.50 Titers |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 14 | 6.73 Titers |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 23F | 4.62 Titers |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 4 | 1.82 Titers |
| Group 4: MMRV + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 23F | 7.03 Titers |
| Group 4: MMRV + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 4 | 3.33 Titers |
| Group 4: MMRV + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 6B | 10.8 Titers |
| Group 4: MMRV + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 9V | 3.57 Titers |
| Group 4: MMRV + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 14 | 10.5 Titers |
| Group 4: MMRV + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 18C | 2.91 Titers |
| Group 4: MMRV + PCV at 12 Months | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Serotype 19F | 4.03 Titers |
Primary
Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)
Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.
Time frame: Day 30 after the 12-month vaccination
Population: Antibody responses were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Measles | 98 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Mumps | 95 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Rubella | 93 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Varicella | 93 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Varicella | 87 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Measles | 98 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Rubella | 88 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Mumps | 95 Percentage of Participants |
Other Pre-specified
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age
Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling. Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Time frame: Days 0 to 7 after vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Irritability | 56 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Solicited Systemic Reaction | 66 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Solicited Injection Site Reacton | 46 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Crying Abnormal (> 3 hours) | 3 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Fever | 10 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Erythema | 23 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Crying Abnormal | 37 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 1 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Vomiting | 1 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Vomiting | 17 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 2 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Appetite Lost | 26 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Drowsiness | 33 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Swelling | 13 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Irritability (Inconsolable) | 5 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 1 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Tenderness | 35 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Solicited Injection Site Reacton | 43 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Tenderness | 33 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Erythema | 20 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Swelling | 11 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Solicited Systemic Reaction | 69 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Fever | 13 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Vomiting | 12 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Vomiting | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Crying Abnormal | 34 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Crying Abnormal (> 3 hours) | 3 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Irritability | 56 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Irritability (Inconsolable) | 3 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Drowsiness | 32 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Appetite Lost | 26 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 2 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Tenderness | 38 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Irritability | 51 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Swelling | 9 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Appetite Lost | 26 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Irritability (Inconsolable) | 2 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 2 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Solicited Injection Site Reacton | 49 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Drowsiness | 35 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Erythema | 23 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Vomiting | 15 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) | 1 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Vomiting | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Fever | 13 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Grade 3 Drowsiness (Sleeps most of time) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Crying Abnormal | 34 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Any Solicited Systemic Reaction | 71 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4
Time frame: Day 30 after 12-month vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 4 | 98 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype18C | 98 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 6B | 100 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 19F | 100 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 14 | 100 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 23F | 100 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 9V | 100 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 23F | 100 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 4 | 99 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 6B | 100 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 9V | 100 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 14 | 100 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype18C | 99 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Serotype 19F | 100 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age
Time frame: Days 0 to 7 after vaccination
Population: Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - PCV | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 1 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Irritability (Inconsolable) | 4 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Irritability | 43 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 24 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Appetite Lost | 24 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Crying Abnormal (> 3 hours) | 1 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Crying Abnormal | 22 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 3 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 34 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Vomiting | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Vomiting | 7 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 13 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - Menactra | 44 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Fever | 10 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 1 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Drowsiness (Sleeps most of time) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Systemic Reaction | 56 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - MMRV | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Drowsiness | 25 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 0 Percentage of Participants |
| Group 1: Menactra® at 9 and 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 32 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - Menactra | 46 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 38 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 23 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 3 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 13 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - MMRV | 38 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 18 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 2 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 11 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - PCV | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Systemic Reaction | 70 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Fever | 21 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) | 3 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Vomiting | 10 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Vomiting | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Crying Abnormal | 41 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Crying Abnormal (> 3 hours) | 3 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Irritability | 58 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Irritability (Inconsolable) | 4 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Drowsiness | 32 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Appetite Lost | 32 Percentage of Participants |
| Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 2 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Appetite Lost | 27 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Irritability (Inconsolable) | 4 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 28 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 3 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - MMRV | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 17 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - Menactra | 57 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 1 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 1 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Drowsiness | 34 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Systemic Reaction | 69 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Fever | 16 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 15 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 51 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) | 3 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Vomiting | 7 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 3 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Vomiting | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Crying Abnormal | 35 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 27 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 1 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Irritability | 60 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - PCV | 54 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 49 Percentage of Participants |
| Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 12 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Vomiting | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 34 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - MMRV | 49 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Irritability (Inconsolable) | 4 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Drowsiness (Sleeps most of time) | 2 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 3 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 42 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Crying Abnormal | 39 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 22 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - Menactra | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 2 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Swelling (≥ 2.0 in) | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Erythema | 23 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Systemic Reaction | 77 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Swelling | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Drowsiness | 39 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Fever | 24 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Appetite Lost | 29 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 1 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Irritability | 62 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) | 3 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Erythema (≥ 2.0 in) | 0 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 2 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Tenderness | 52 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Vomiting | 10 Percentage of Participants |
| Group 4: MMRV + PCV at 12 Months | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Any Solicited Injection Site Reaction - PCV | 62 Percentage of Participants |