Diphtheria, Meningitis, Meningococcemia, Pertussis, Tetanus
Conditions
Keywords
Meningitis, Meningococcemia, Pertussis, Neisseria meningitidis, Tetanus, Diphtheria
Brief summary
The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately. Secondary Objective: To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.
Interventions
BIOLOGICALT dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
BIOLOGICALTdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
BIOLOGICALMeningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
: * Healthy as determined by medical history and physical examination. * Aged ≥ 11 to 17 years at the time of study vaccination on Day 0. * Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian. * Informed assent form that has been approved by the IRB signed by the subject. * Subject (female) agrees to use measures to prevent pregnancy during the study.
Exclusion criteria
: * Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.). * Known or suspected impairment of immunologic function. * Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment. * History of documented invasive meningococcal disease or previous meningococcal vaccination. * History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years. * 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 enrolment. * Received antibiotic therapy within the 72 hours prior to vaccination on Day 0. * Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study. * Suspected or known hypersensitivity to either of the two study vaccines or their components. * 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 investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * For all females, a positive or equivocal urine pregnancy test at time of study vaccination. * Nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Day 0 to Day 28 post-vaccination |
| Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Day 0 and Day 28 post-vaccination |
| Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Day 0 and Day 28 Post-vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | 0 to 7 days post-vaccination | Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 26 April 2005 through 24 June 2005 in 21 Medical centers in the US
Pre-assignment details
A total of 1345 participants that met the inclusion and exclusion criteria were randomized and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Tdap + Placebo Vaccines Day 0 Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later | 444 |
| Tdap + Menactra® Vaccines Day 0 Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later | 450 |
| Menactra® + Placebo Vaccines Day 0 Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later. | 451 |
| Total | 1,345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 3 | 2 |
| Overall Study | Protocol Violation | 2 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 6 | 5 |
Baseline characteristics
| Characteristic | Menactra® + Placebo Vaccines Day 0 | Total | Tdap + Placebo Vaccines Day 0 | Tdap + Menactra® Vaccines Day 0 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 451 Participants | 1345.0 Participants | 444 Participants | 450 Participants |
| Age, Categorical >=65 years | 0 Participants | 0.0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0.0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.3 years STANDARD_DEVIATION 2.05 | 13.1 years STANDARD_DEVIATION 1.95 | 13.0 years STANDARD_DEVIATION 1.87 | 13.0 years STANDARD_DEVIATION 1.93 |
| Region of Enrollment United States | 451 participants | 1345.0 participants | 444 participants | 450 participants |
| Sex: Female, Male Female | 186 Participants | 599.0 Participants | 220 Participants | 193 Participants |
| Sex: Female, Male Male | 265 Participants | 746.0 Participants | 224 Participants | 257 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 | 0 / 444 | 0 / 450 | 0 / 451 |
| serious Total, serious adverse events | 2 / 444 | 1 / 450 | 1 / 451 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Time frame: Day 0 and Day 28 post-vaccination
Population: Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Tetanus toxoid - Day 28 | 22.8 IU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Tetanus toxoid - Day 0 | 0.9 IU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Diphtheria toxoid - Day 28 | 7.9 IU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Diphtheria toxoid - Day 0 | 0.2 IU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Diphtheria toxoid - Day 28 | 49.8 IU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Tetanus toxoid - Day 28 | 16.4 IU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Diphtheria toxoid - Day 0 | 0.3 IU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Tetanus toxoid - Day 0 | 0.8 IU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Tetanus toxoid - Day 28 | 21.1 IU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Diphtheria toxoid - Day 0 | 56.2 IU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Tetanus toxoid - Day 0 | 1.0 IU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Diphtheria toxoid - Day 28 | 38.2 IU/mL |
Primary
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Time frame: Day 0 and Day 28 Post-vaccination
Population: Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertactin - Day 28 | 176.5 EU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Filamentous Haemagglutinin - Day 28 | 179.5 EU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Fimbriae Types 2 and 3 - Day 28 | 1133.4 EU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertactin - Day 0 | 9.0 EU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Fimbriae Types 2 and 3 - Day 0 | 13.8 EU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertussis Toxoid - Day 28 | 88.0 EU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Filamentous Haemagglutinin - Day 0 | 21.4 EU/mL |
| Tdap + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertussis Toxoid - Day 0 | 15.3 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertussis Toxoid - Day 28 | 73.4 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertussis Toxoid - Day 0 | 14.0 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Filamentous Haemagglutinin - Day 0 | 20.0 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Filamentous Haemagglutinin - Day 28 | 140.2 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertactin - Day 0 | 8.4 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertactin - Day 28 | 130.3 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Fimbriae Types 2 and 3 - Day 0 | 12.7 EU/mL |
| Tdap + Menactra® Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Fimbriae Types 2 and 3 - Day 28 | 699.1 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertussis Toxoid - Day 28 | 107.4 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertactin - Day 28 | 213.6 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertussis Toxoid - Day 0 | 20.7 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Fimbriae Types 2 and 3 - Day 28 | 832.3 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Filamentous Haemagglutinin - Day 28 | 245.1 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Fimbriae Types 2 and 3 - Day 0 | 14.2 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Pertactin - Day 0 | 11.9 EU/mL |
| Menactra® + Placebo Vaccines Day 0 | Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. | Filamentous Haemagglutinin - Day 0 | 28.5 EU/mL |
Primary
Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Time frame: Day 0 to Day 28 post-vaccination
Population: Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup A | 92 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup C | 80 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup Y | 79 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup W-135 | 94 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup W-135 | 96 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup A | 94 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup Y | 87 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup C | 84 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup W-135 | 96 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup C | 87 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup Y | 87 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. | Meningococcal Serogroup A | 93 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.
Time frame: 0 to 7 days post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants intend-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Fever (≥ 40.0 °C, Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Inj. Site Reaction-Placebo, Dose 1 | 38 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Myalgia (prevents daily activities, Dose 1) | 2 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Fever (Dose 1) | 2 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Solicited Inj. Site Reaction-Placebo, Dose 1 | 1 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Headache (prevents daily activities, Dose 2) | 3 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Systemic Reaction (Dose 1) | 5 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 11 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 5 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Systemic Reaction (Dose 1) | 74 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 1 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Headache (Dose 2) | 27 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 2) | 2 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 11 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Fever (≥ 40.0 °C, Dose 2) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 2) | 51 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 1 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 85 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 2) | 11 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 33 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Injection Site Reaction-Tdap, Dose 1 | 87 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 2) | 2 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Fever (Dose 2) | 1 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 2) | 13 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Injection Site Reaction (Dose 2) | 56 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 4 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Inj. Site Reaction (Dose 2) | 4 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Systemic Reaction (Dose 2) | 4 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Inj. Site Reaction-Menactra, Dose 1 | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Myalgia (Dose 2) | 29 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Systemic Reaction (Dose 2) | 48 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Solicited Inj Site Reaction-Menactra, Dose 1 | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Inj. Site Reaction-Tdap, Dose 1 | 10 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Myalgia (Dose 1) | 60 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 2) | 2 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Malaise (prevents daily activities, Dose 1) | 3 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Malaise (prevents daily activities, Dose 2) | 3 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 25 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Malaise (Dose 2) | 19 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Malaise (Dose 1) | 30 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 4 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Headache (prevents daily activities, Dose 1) | 2 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Myalgia (prevents daily activities, Dose 2) | 1 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Headache (Dose 1) | 37 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 0 Percentage of participants |
| Tdap + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 26 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Malaise (Dose 1) | 30 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 30 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 2) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Injection Site Reaction-Tdap, Dose 1 | 84 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Inj. Site Reaction-Tdap, Dose 1 | 9 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 3 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 24 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 5 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 81 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 4 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Inj. Site Reaction-Menactra, Dose 1 | 57 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Solicited Inj Site Reaction-Menactra, Dose 1 | 4 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 19 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 2 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 14 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 2 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 52 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 1 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Inj. Site Reaction-Placebo, Dose 1 | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Solicited Inj. Site Reaction-Placebo, Dose 1 | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Injection Site Reaction (Dose 2) | 24 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Inj. Site Reaction (Dose 2) | 8 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 2) | 8 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 2) | 1 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 2) | 6 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 2) | 20 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 2) | 1 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Systemic Reaction (Dose 1) | 69 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Systemic Reaction (Dose 1) | 7 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Fever (Dose 1) | 4 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Fever (≥ 40.0 °C, Dose 1) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Headache (Dose 1) | 38 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Headache (prevents daily activities, Dose 1) | 4 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Malaise (prevents daily activities, Dose 1) | 4 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Myalgia (Dose 1) | 54 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Myalgia (prevents daily activities, Dose 1) | 2 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Systemic Reaction (Dose 2) | 33 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Systemic Reaction (Dose 2) | 3 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Fever (Dose 2) | 1 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Fever (≥ 40.0 °C, Dose 2) | 0 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Headache (Dose 2) | 22 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Headache (prevents daily activities, Dose 2) | 2 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Malaise (Dose 2) | 13 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Malaise (prevents daily activities, Dose 2) | 1 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Myalgia (Dose 2) | 15 Percentage of participants |
| Tdap + Menactra® Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Myalgia (prevents daily activities, Dose 2) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Inj. Site Reaction-Placebo, Dose 1 | 35 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Injection Site Reaction-Tdap, Dose 1 | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Fever (Dose 1) | 2 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Headache (Dose 2) | 26 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Fever (≥ 40.0 °C, Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 52 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Headache (Dose 1) | 37 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 2 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Myalgia (prevents daily activities, Dose 2) | 3 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Headache (prevents daily activities, Dose 1) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 15 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 2 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Malaise (Dose 1) | 25 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 16 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Headache (prevents daily activities, Dose 2) | 3 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Malaise (prevents daily activities, Dose 1) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Solicited Inj Site Reaction-Menactra, Dose 1 | 4 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Myalgia (Dose 1) | 41 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Myalgia (Dose 2) | 44 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Myalgia (prevents daily activities, Dose 1) | 2 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Inj. Site Reaction-Menactra, Dose 1 | 58 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Malaise (Dose 2) | 20 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Systemic Reaction (Dose 2) | 54 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Injection Site Reaction (Dose 2) | 68 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Inj. Site Reaction-Tdap, Dose 1 | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Inj. Site Reaction (Dose 2) | 6 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 1) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Systemic Reaction (Dose 2) | 6 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 2) | 14 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 30 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 2) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 2) | 14 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 2) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any swelling (Dose 1) | 9 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Fever (Dose 2) | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Pain (Dose 2) | 65 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Erythema (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 swelling (≥ 2 inches, Dose 1) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Pain (Incapacitating, Dose 2) | 5 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Erythyma (Dose 1) | 11 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Malaise (prevents daily activities, Dose 2) | 3 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Any Solicited Systemic Reaction (Dose 1) | 61 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grd 3 Solicited Inj. Site Reaction-Placebo, Dose 1 | 1 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Fever (≥ 40.0 °C, Dose 2) | 0 Percentage of participants |
| Menactra® + Placebo Vaccines Day 0 | Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. | Grade 3 Solicited Systemic Reaction (Dose 1) | 3 Percentage of participants |