Diphtheria, Meningococcal Meningitis, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Meningococcal meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis, Neisseria meningitidis
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
Interventions
BIOLOGICALPolysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, as determined by medical history and physical examination. * Aged 4 to \< 7 years at the time of study vaccination on Day 0. * Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian. * Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.
Exclusion criteria
* Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic) * Known or suspected impairment of immunologic function * Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment * History of documented invasive meningococcal disease or previous meningococcal vaccination * Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study. * 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 2 weeks prior to enrollment. * Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw. * Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances. * Thrombocytopenia or a bleeding disorder contraindicating IM vaccination. * Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures. * Enrolled in another clinical trial. * Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study. * Personal or family history of Guillain-Barré Syndrome (GBS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination | Day 30 post-vaccination (Visit 1) | Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay. |
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Day 30 post-vaccination (Visit 1) | Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Day 30 post-vaccination | Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC) |
| Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Day 30 post-vaccination 1 | Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA). |
| Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine | Day 0 through Day 7 post-vaccination at Visit 1 | Fever was defined as a maximum oral temperature of ≥ 100.4ºF. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Day 0 through Day 7 post-vaccination | Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. |
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Day 0 through Day 7 post-vaccination | Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. |
| Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Day 30 post-vaccination | Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 16 October 2006 to 21 June 2007 in 45 medical centers in the US.
Pre-assignment details
A total of 881 participants who met the inclusion and exclusion criteria were enrolled. Data on 879 that were vaccinated are presented in this reported.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2 | 353 |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2 | 353 |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2 | 175 |
| Total | 881 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Did not receive study vaccine | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 7 | 1 |
| Overall Study | Protocol Violation | 7 | 9 | 1 |
| Overall Study | Serious adverse events | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 10 | 2 |
Baseline characteristics
| Characteristic | Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 353 Participants | 175 Participants | 353 Participants | 881 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 | 4.5 Years STANDARD_DEVIATION 0.51 | 4.5 Years STANDARD_DEVIATION 0.49 | 4.5 Years STANDARD_DEVIATION 0.48 | 4.5 Years STANDARD_DEVIATION 0.5 |
| Region of Enrollment United States | 353 participants | 175 participants | 353 participants | 881 participants |
| Sex: Female, Male Female | 182 Participants | 73 Participants | 172 Participants | 427 Participants |
| Sex: Female, Male Male | 171 Participants | 102 Participants | 181 Participants | 454 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 | 236 / 341 | 229 / 344 | 98 / 169 |
| serious Total, serious adverse events | 0 / 341 | 2 / 344 | 1 / 169 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time frame: Day 30 post-vaccination (Visit 1)
Population: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup A (N = 0, 131, 104) | 10.8 Titers |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup C (N = 0, 131, 103) | 8.1 Titers |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup Y (N = 0, 131, 104) | 18.1 Titers |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup W-135 (N = 0, 131, 104) | 22.8 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup W-135 (N = 0, 131, 104) | 21.7 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup A (N = 0, 131, 104) | 10.4 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup Y (N = 0, 131, 104) | 26.2 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serogroup C (N = 0, 131, 103) | 7.8 Titers |
Primary
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Time frame: Day 30 post-vaccination (Visit 1)
Population: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination | Diphtheria Antibody Concentration ≥ 1.0 IU/mL | 249 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination | Tetanus Antibody Concentration ≥ 1.0 IU/mL | 246 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination | Diphtheria Antibody Concentration ≥ 1.0 IU/mL | 238 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination | Tetanus Antibody Concentration ≥ 1.0 IU/mL | 236 Participants |
Secondary
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Time frame: Day 30 post-vaccination 1
Population: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Pertussis toxoid (PT; N = 243, 236, 0) | 70.0 EU/mL |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Filamentous hemagglutinin (FHA; N = 246, 237, 0) | 133 EU/mL |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Fimbriae Types 2 and 3 (FIM; N = 243, 238, 0) | 123 EU/mL |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Pertactin (PRN; N = 247, 238, 0) | 115 EU/mL |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Pertactin (PRN; N = 247, 238, 0) | 118 EU/mL |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Pertussis toxoid (PT; N = 243, 236, 0) | 71.0 EU/mL |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Fimbriae Types 2 and 3 (FIM; N = 243, 238, 0) | 113 EU/mL |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Filamentous hemagglutinin (FHA; N = 246, 237, 0) | 145 EU/mL |
Secondary
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Time frame: Day 0 through Day 7 post-vaccination at Visit 1
Population: Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine | 27 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine | 18 Participants |
Secondary
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time frame: Day 30 post-vaccination
Population: Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup A (N = 137, 0, 104) | 6.7 Titers |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup C (N = 138, 0, 103) | 3.3 Titers |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup Y (N = 138, 0, 104) | 6.5 Titers |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup W-135 (N = 138, 0, 104) | 8.4 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup W-135 (N = 138, 0, 104) | 21.7 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup A (N = 137, 0, 104) | 10.4 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup Y (N = 138, 0, 104) | 26.2 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serogroup C (N = 138, 0, 103) | 7.8 Titers |
Other Pre-specified
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.
Time frame: Day 30 post-vaccination
Population: Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 2 (N = 245, 237, 120) | 5209.5 Titers |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 1 (N = 243, 235, 120) | 5094.8 Titers |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 3 (N = 245, 236, 120) | 6777.5 Titers |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 2 (N = 245, 237, 120) | 6195.6 Titers |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 1 (N = 243, 235, 120) | 5767 Titers |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 3 (N = 245, 236, 120) | 7815.9 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 1 (N = 243, 235, 120) | 4885.1 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 3 (N = 245, 236, 120) | 5843 Titers |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Geometric Mean Titers Against Poliovirus After IPOL Vaccination. | Type 2 (N = 245, 237, 120) | 5373.6 Titers |
Other Pre-specified
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time frame: Day 0 through Day 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: Menactra | NA Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): DAPTACEL | 2 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: DAPTACEL | 161 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): DAPTACEL | 75 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: DAPTACEL | 113 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): DAPTACEL | 54 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: DAPTACEL | 236 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): Menactra | NA Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: Menactra | NA Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): Menactra | NA Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: Menactra | NA Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): Menactra | NA Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: IPOL | 207 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): IPOL | 3 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: IPOL | 59 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): IPOL | 10 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: IPOL | 39 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): IPOL | 8 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Fever | 27 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) | 1 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Headache | 48 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Malaise | 86 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Malaise (Prevents daily activities) | 8 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Myalgia | 153 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Myalgia (Prevents daily activities) | 6 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: Menactra | 103 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Headache | 42 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): Menactra | 16 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: Menactra | 66 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Myalgia | 123 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): Menactra | 18 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: IPOL | NA Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): IPOL | NA Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: IPOL | NA Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Malaise | 81 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): IPOL | NA Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: IPOL | NA Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): IPOL | NA Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: DAPTACEL | 229 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): DAPTACEL | 2 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Malaise (Prevents daily activities) | 2 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: DAPTACEL | 161 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Fever | 18 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): DAPTACEL | 73 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: DAPTACEL | 109 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): DAPTACEL | 41 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) | 3 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: Menactra | 201 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): Menactra | 1 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Myalgia (Prevents daily activities) | 3 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: Menactra | 93 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: DAPTACEL | NA Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: DAPTACEL | NA Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): Menactra | 6 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Headache | 22 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): IPOL | 2 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: Menactra | 21 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Malaise (Prevents daily activities) | 5 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): DAPTACEL | NA Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): Menactra | 5 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) | 0 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Swelling (≥ 2 in): DAPTACEL | NA Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Pain: IPOL | 98 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: DAPTACEL | NA Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): IPOL | 2 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Myalgia | 44 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: Menactra | 31 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Erythema: IPOL | 23 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Pain (Incapacitating): Menactra | 2 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): DAPTACEL | NA Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Erythema (≥ 2 in): IPOL | 2 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Malaise | 44 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Fever | 13 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Any Injection Site Swelling: IPOL | 12 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
Other Pre-specified
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time frame: Day 0 through Day 7 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: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Pain | 168 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Swelling (≥ 2 inches) | 19 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Myalgia | 78 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Headache | 27 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Fever | 12 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Erythema | 80 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) | 1 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Myalgia (Prevents daily activities) | 2 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Malaise (Prevents daily activities) | 4 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Erythema (≥ 2 inches) | 24 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Pain (Incapacitating) | 2 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Malaise | 46 Participants |
| Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Swelling | 58 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Malaise | 47 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Pain | 128 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Pain (Incapacitating) | 1 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Erythema | 54 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Erythema (≥ 2 inches) | 2 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Swelling | 31 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Swelling (≥ 2 inches) | 1 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Fever | 17 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) | 1 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Headache | 21 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Headache (Prevents daily activities) | 2 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Malaise (Prevents daily activities) | 8 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Myalgia | 55 Participants |
| Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Myalgia (Prevents daily activities) | 3 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Myalgia | 42 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Headache (Prevents daily activities) | 1 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Erythema (≥ 2 inches) | 18 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Headache | 12 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Malaise | 37 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Erythema | 42 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Pain | 85 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Malaise (Prevents daily activities) | 3 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Fever | 11 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Pain (Incapacitating) | 0 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF) | 0 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Swelling (≥ 2 inches) | 10 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Grade 3 Myalgia (Prevents daily activities) | 1 Participants |
| Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 | Any Injection Site Swelling | 32 Participants |