Diphtheria, Haemophilus Influenzae Serotype b (Hib), Meningitis, Meningococcal Infection, Pertussis, Tetanus
Conditions
Keywords
Meningitis, Meningococcal Infection, Diphtheria, Pertussis, Menactra®, Pentacel®
Brief summary
The aim of the study is to further characterize the safety and immunogenicity of Menactra® in the population \<2 years of age when administered alone and when the second dose is administered concomitantly with the 4th dose of Pentacel®, a licensed pediatric vaccine. Primary Objectives: * To evaluate and compare the antibody responses to meningococcal serogroups A, C, Y, and W-135 induced by 2 injections of Menactra® in subjects aged 9 months at the first vaccination visit and 15 to 18 months at the second vaccination visit. * To evaluate and compare the antibody responses to Pertussis (pertussis toxoid \[PT\], filamentous haemagglutinin \[FHA\] and pertactin \[PRN\]) antigens induced by a dose of Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of Pentacel® administered alone. * To evaluate and compare the antibody responses to polyribosylribitol phosphate (PRP), tetanus and diphtheria antigens induced by a dose of Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of Pentacel® alone. Observational Objectives: * To describe the safety profile (immediate unsolicited AEs within 30 minutes of each trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited AEs within 30 days of each vaccination, and serious adverse events \[SAEs\] throughout the course of the trial from Day 0 up to Day 30 after the last trial vaccination\[s\]) in all trial groups * To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by SBA HC, 30 days after the second Menactra® administration * To describe the antibody responses to Pentacel® (PT, FHA, PRN, FIM, diphtheria, tetanus, polio, PRP) measured by enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), or functional assays.
Detailed description
Participants will be vaccinated according to their randomized groups at age 9 months and at age 15 to 18 months. They will undergo immunogenicity assessment and safety monitoring post-vaccination.
Interventions
0.5 mL, Intramuscular
BIOLOGICALMeningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed
0.5 mL, Intramuscular
BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 9 months (249 to 305 days) for Groups 1 and 2, or 15 to 18 months (420 to 570 days) for Group 3 on the day of the first trial visit * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * Received 3 doses of any DTaP-containing vaccines * Received 3 doses of a Hib-containing vaccine, or 2 doses if the subject received PRP-OMP (PedvaxHIB® or Comvax®\[HepB-Hib\]) * Received at least 3 doses of a CRM197-based pneumococcal conjugate vaccine (Pneumococcal conjugate vaccine \[PCV\] or 13-Valent pneumococcal conjugate vaccine \[PCV13\]) * Subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before or after the trial vaccination(s) * Vaccination against meningococcal disease with either the trial vaccine or another vaccine, or receipt of the 4th dose of any DTaP-containing vaccines, receipt of the 4th dose of a Hib-containing vaccine, or receipt of the 3rd dose of PRP-OMP (PedvaxHIB® or Comvax® \[Hep B-Hib\]) prior to enrollment or during the conduction of the trial, except for Group 1 subjects, who may receive Hib vaccine at 12 months * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Topical steroids are not included in this exclusion criterion * History of invasive meningococcal infection, confirmed either clinically, serologically, or microbiologically * Personal history of Guillain-Barré Syndrome * History of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to one of the vaccines used in the trial or to a vaccine containing any of the same substances * Known thrombocytopenia, as reported by the parent/ legally acceptable representative, contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * In an emergency setting or hospitalized involuntarily * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/ infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]) on the day of vaccination. A prospective subject should not be included in the trial until the condition has resolved or the febrile event has subsided * Receipt of oral or injectable antibiotic therapy within 72 hours prior to any trial blood draw (topical antibiotics, drops, or ointments are not included in this criterion) * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Day 30 post second Menactra vaccination | Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC). Menactra vaccine response defined as subjects with an hSBA titer \<1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer. |
| Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Day 30 post-vaccination 2 | Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Day 30 post-vaccination 2 | Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is \<4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ |
| Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Day 30 post-vaccination 2 | Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test. The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Day 0 (pre-vaccination) and Day 30 post-vaccination 2 | Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2 |
| Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Day 0 to Day 7 after the 15 to 18 month vaccination | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable. |
| Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Day 0 (pre-vaccination) and Day 30 post-vaccination 2 | Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test. |
| Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Day 0 to Day 7 after any vaccination | Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable. |
| Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Day 0 to Day 7 after 9-month vaccination | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled from 24 July 2012 to 14 June 2013 in 62 clinical centers in the United States.
Pre-assignment details
A total of 1394 participants were enrolled for the study, data on 1288 participants who met all the inclusion and none of the exclusion criteria and who completed the vaccination schedule are presented in this report.
Participants by arm
| Arm | Count |
|---|---|
| Menactra Vaccine Group Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months | 421 |
| Menactra + Pentacel Vaccine Group Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months | 395 |
| Pentacel Vaccine Group Study participants received only Pentacel vaccine at 15 to 18 months of age | 472 |
| Total | 1,288 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 3 | 2 |
| Overall Study | Protocol Violation | 3 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 5 |
Baseline characteristics
| Characteristic | Menactra + Pentacel Vaccine Group | Pentacel Vaccine Group | Menactra Vaccine Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 395 Participants | 472 Participants | 421 Participants | 1288 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 | 284.6 Days STANDARD_DEVIATION 10.6 | 483.9 Days STANDARD_DEVIATION 30.3 | 284.5 Days STANDARD_DEVIATION 10.8 | 353.6 Days STANDARD_DEVIATION 96.8 |
| Region of Enrollment United States | 395 Participants | 472 Participants | 421 Participants | 1288 Participants |
| Sex: Female, Male Female | 171 Participants | 232 Participants | 219 Participants | 622 Participants |
| Sex: Female, Male Male | 224 Participants | 240 Participants | 202 Participants | 666 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 | 296 / 421 | 318 / 395 | 380 / 472 |
| serious Total, serious adverse events | 13 / 421 | 11 / 395 | 1 / 472 |
Outcome results
Primary
Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 30 post-vaccination 2
Population: Geometric Mean Concentrations (GMC) of Pertussis vaccine antibodies were assessed in the Per-protocol population of participants in Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra + Pentacel Vaccine Group | Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertussis Toxoid (PT; N=0, 332, 417) | 73.5 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Filamentous hemagglutinin FHA; N=0, 331, 417) | 113.7 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertactin (PRN; N=0, 331, 417) | 120.9 Titers |
| Pentacel Vaccine Group | Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertussis Toxoid (PT; N=0, 332, 417) | 69.7 Titers |
| Pentacel Vaccine Group | Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Filamentous hemagglutinin FHA; N=0, 331, 417) | 110.1 Titers |
| Pentacel Vaccine Group | Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertactin (PRN; N=0, 331, 417) | 133.9 Titers |
Comparison: Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively95% CI: [0.852, 1.06]
Comparison: Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively95% CI: [0.866, 1.08]
Comparison: Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively95% CI: [0.937, 1.31]
Primary
Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test. The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3.
Time frame: Day 30 post-vaccination 2
Population: Antibody responses to Diphtheria, Tetanus, and Polyribosylribitol phosphate antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra + Pentacel Vaccine Group | Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Diphtheria (N=0, 324, 416) | 99.69 Percentage of Participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Tetanus (N=0, 326, 415) | 100.00 Percentage of Participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polyribosylribitol phosphate (N=0, 324, 416) | 97.53 Percentage of Participants |
| Pentacel Vaccine Group | Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Tetanus (N=0, 326, 415) | 100.00 Percentage of Participants |
| Pentacel Vaccine Group | Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Diphtheria (N=0, 324, 416) | 100.00 Percentage of Participants |
| Pentacel Vaccine Group | Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polyribosylribitol phosphate (N=0, 324, 416) | 97.12 Percentage of Participants |
Primary
Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is \<4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ
Time frame: Day 30 post-vaccination 2
Population: Antibody responses to Pertussis vaccine antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra + Pentacel Vaccine Group | Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertussis Toxoid (PT; N=0, 330, 417) | 90.91 Percentage of Participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Filamentous hemagglutinin (FHA; N=0,329, 417) | 93.62 Percentage of Participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertactin (PRN; N=0, 329, 417) | 93.62 Percentage of Participants |
| Pentacel Vaccine Group | Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertussis Toxoid (PT; N=0, 330, 417) | 89.69 Percentage of Participants |
| Pentacel Vaccine Group | Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Filamentous hemagglutinin (FHA; N=0,329, 417) | 94.48 Percentage of Participants |
| Pentacel Vaccine Group | Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Pertactin (PRN; N=0, 329, 417) | 93.53 Percentage of Participants |
Comparison: Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.95% CI: [-5.44, 3.19]
Comparison: Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.95% CI: [-2.54, 4.53]
Comparison: Pertactin (PRN) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.95% CI: [-3.62, 3.66]
Primary
Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination
Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC). Menactra vaccine response defined as subjects with an hSBA titer \<1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer.
Time frame: Day 30 post second Menactra vaccination
Population: Antibody titers to the meningococcal serogroups were assessed in the Per-protocol population of the participants in Menactra Vaccine Group and Menactra + Pentacel Vaccine Group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup A (N=346, 329, 0) | 96.24 Percentage of participants |
| Menactra Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup Y (N=351, 333, 0) | 98.86 Percentage of participants |
| Menactra Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup C (N=352, 333, 0) | 98.86 Percentage of participants |
| Menactra Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup W-135 (N=351, 330, 0) | 98.86 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup C (N=352, 333, 0) | 97.60 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup A (N=346, 329, 0) | 96.35 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup W-135 (N=351, 330, 0) | 97.58 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination | Serogroup Y (N=351, 333, 0) | 96.40 Percentage of participants |
Comparison: Meningococcal serogroup A: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.95% CI: [-3.11, 2.93]
Comparison: Meningococcal serogroup C: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.95% CI: [-0.84, 3.64]
Comparison: Meningococcal serogroup Y: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.95% CI: [0.14, 5.14]
Comparison: Meningococcal serogroup W-135: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.95% CI: [-0.84, 3.67]
Other Pre-specified
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test.
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination 2
Population: Geometric mean titers of individual vaccine antibodies were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and the Pentacel Vaccine Group participants.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-FIM (pre-vaccination; N=0, 335, 418) | 17.6 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-FIM (post-vaccination; N=0, 332, 417) | 220.8 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-PRN (pre-vaccination; N=0, 334, 418) | 10.3 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-PRN (post-vaccination; N=0, 331, 417) | 120.9 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Diphtheria (pre-vaccination; N=0, 328, 418) | 0.3 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Diphtheria (post-vaccination; N=0, 324, 416) | 3.3 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Tetanus (pre-vaccination; N=0, 329, 414) | 0.2 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Tetanus (post-vaccination; N=0, 326, 415) | 3.7 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 1 (pre-vaccination; N=0, 326, 415) | 83.1 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 1 (post-vaccination; N=0, 323, 414) | 2140 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 2 (pre-vaccination; N=0, 328, 417) | 157.0 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 2 (post-vaccination; N=0, 324, 414) | 3172 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 3 (pre-vaccination; N=0, 327, 417) | 107.1 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 3 (post-vaccination; N=0, 323, 415) | 4629 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 2 (pre-vaccination; N=0, 328, 417) | 182.8 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-FIM (pre-vaccination; N=0, 335, 418) | 23.2 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Tetanus (post-vaccination; N=0, 326, 415) | 3.9 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-FIM (post-vaccination; N=0, 332, 417) | 265.5 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 3 (pre-vaccination; N=0, 327, 417) | 130.2 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-PRN (pre-vaccination; N=0, 334, 418) | 11.1 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 1 (pre-vaccination; N=0, 326, 415) | 76.9 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-PRN (post-vaccination; N=0, 331, 417) | 133.9 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 2 (post-vaccination; N=0, 324, 414) | 3071 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Diphtheria (pre-vaccination; N=0, 328, 418) | 0.2 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 1 (post-vaccination; N=0, 323, 414) | 1887 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Diphtheria (post-vaccination; N=0, 324, 416) | 4.2 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Polio 3 (post-vaccination; N=0, 323, 415) | 3765 Titers |
| Pentacel Vaccine Group | Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Anti-Tetanus (pre-vaccination; N=0, 329, 414) | 0.2 Titers |
Other Pre-specified
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine
Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination 2
Population: Geometric mean titers of individual antibodies were assessed in the Per-protocol population in the Menactra Vaccine Group and Menactra + Pentacel Vaccine Group participants.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup A (Pre-vaccination; N=352, 332, 0) | 3.4 Titers |
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup A (Post-vaccination; N=350, 332, 0) | 104.8 Titers |
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup C (Pre-vaccination; N=352, 332, 0) | 2.2 Titers |
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup C (Post-vaccination; N=350, 332, 0) | 157.9 Titers |
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup Y (Pre-vaccination; N=352, 332, 0) | 2.1 Titers |
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup Y (Post-vaccination; N=350, 332, 0) | 77.8 Titers |
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup W-135 (Pre-vaccination; N=352, 332, 0) | 2.1 Titers |
| Menactra Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup W-135 (Post-vaccination; N=350, 332, 0) | 90.3 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup W-135 (Post-vaccination; N=350, 332, 0) | 81.1 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup A (Pre-vaccination; N=352, 332, 0) | 4.3 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup Y (Pre-vaccination; N=352, 332, 0) | 2.1 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup A (Post-vaccination; N=350, 332, 0) | 104.5 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup W-135 (Pre-vaccination; N=352, 332, 0) | 2.1 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup C (Pre-vaccination; N=352, 332, 0) | 2.1 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup Y (Post-vaccination; N=350, 332, 0) | 62.2 Titers |
| Menactra + Pentacel Vaccine Group | Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine | Serogroup C (Post-vaccination; N=350, 332, 0) | 129.1 Titers |
Other Pre-specified
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine.
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable.
Time frame: Day 0 to Day 7 after 9-month vaccination
Population: Solicited reactions were assessed in subjects who received at least one dose of study vaccine at 9 month of age, according to the vaccine actually received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Irritability (N = 419, 387, 0) | 4.8 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any injection-site Tenderness (N = 419, 387, 0) | 32.2 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 injection-site Tenderness (N=419, 387, 0) | 0.2 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any injection-site Erythema (N = 419, 387, 0) | 16.9 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 injection-site Erythema (N = 419, 387, 0) | 0.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any injection-site Swelling (N = 419, 385, 0) | 10.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 injection-site Swelling (N = 419, 385, 0) | 0.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Fever (N = 421, 389, 0) | 10.5 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Fever (N = 421, 389, 0) | 0.7 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Vomiting (N = 419, 387, 0) | 15.5 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Vomiting (N = 419, 387, 0) | 0.5 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Crying abnormal (N = 419, 387, 0) | 38.9 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Drowsiness (N = 419, 387, 0) | 37.2 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Drowsiness (N = 419, 387, 0) | 2.1 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Appetite lost (N = 419, 387, 0) | 25.3 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Appetite lost (N = 419, 387, 0) | 1.4 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Irritability (N = 419, 387, 0) | 56.1 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Crying abnormal (N = 419, 387, 0) | 3.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Irritability (N = 419, 387, 0) | 54.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Irritability (N = 419, 387, 0) | 3.1 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Vomiting (N = 419, 387, 0) | 12.9 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any injection-site Tenderness (N = 419, 387, 0) | 34.1 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Drowsiness (N = 419, 387, 0) | 0.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 injection-site Tenderness (N=419, 387, 0) | 0.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Vomiting (N = 419, 387, 0) | 0.0 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any injection-site Erythema (N = 419, 387, 0) | 24.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Appetite lost (N = 419, 387, 0) | 1.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 injection-site Erythema (N = 419, 387, 0) | 0.0 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Crying abnormal (N = 419, 387, 0) | 37.5 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any injection-site Swelling (N = 419, 385, 0) | 9.4 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Crying abnormal (N = 419, 387, 0) | 2.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 injection-site Swelling (N = 419, 385, 0) | 0.0 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Appetite lost (N = 419, 387, 0) | 28.7 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Fever (N = 421, 389, 0) | 10.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Any Drowsiness (N = 419, 387, 0) | 37.0 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. | Grade 3 Fever (N = 421, 389, 0) | 1.5 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable.
Time frame: Day 0 to Day 7 after any vaccination
Population: Solicited reactions were assessed in all subjects who received at least one dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Irritability (N = 420, 393, 463) | 70.5 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Crying abnormal (N = 420, 393, 463) | 52.9 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Fever (N = 421, 394, 463) | 16.9 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-siteTenderness (N = 420, 393, 463) | 1.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Vomiting (N = 420, 393, 463) | 0.5 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Fever (N = 421, 394, 463) | 1.4 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Appetite lost (N = 420, 393, 463) | 2.1 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Vomiting (N = 420, 393, 463) | 22.6 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Erythema (N = 420, 393, 463) | 25.2 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Irritability (N = 420, 393, 463) | 6.4 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Appetite lost (N = 420, 393, 463) | 43.3 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Erythema (N = 420, 393, 463) | 0.2 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Tenderness (N = 420, 393, 463) | 52.1 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Drowsiness (N = 420, 393, 463) | 49.8 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Swelling (N = 420, 393, 463) | 15.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Drowsiness (N = 421, 394, 463) | 3.1 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Crying abnormal (N = 420, 393, 463) | 4.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Swelling (N = 420, 393, 463) | 0.0 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Drowsiness (N = 421, 394, 463) | 2.0 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Tenderness (N = 420, 393, 463) | 61.6 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Erythema (N = 420, 393, 463) | 38.7 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Erythema (N = 420, 393, 463) | 0.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Swelling (N = 420, 393, 463) | 23.2 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Swelling (N = 420, 393, 463) | 0.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Fever (N = 421, 394, 463) | 21.6 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Fever (N = 421, 394, 463) | 2.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Vomiting (N = 420, 393, 463) | 17.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Vomiting (N = 420, 393, 463) | 0.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Crying abnormal (N = 420, 393, 463) | 52.2 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Crying abnormal (N = 420, 393, 463) | 5.1 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Drowsiness (N = 420, 393, 463) | 52.4 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-siteTenderness (N = 420, 393, 463) | 4.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Appetite lost (N = 420, 393, 463) | 47.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Appetite lost (N = 420, 393, 463) | 3.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Irritability (N = 420, 393, 463) | 72.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Irritability (N = 420, 393, 463) | 6.9 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Irritability (N = 420, 393, 463) | 58.5 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Crying abnormal (N = 420, 393, 463) | 2.2 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Erythema (N = 420, 393, 463) | 1.1 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Appetite lost (N = 420, 393, 463) | 1.3 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Drowsiness (N = 420, 393, 463) | 30.0 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Tenderness (N = 420, 393, 463) | 51.4 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Drowsiness (N = 421, 394, 463) | 1.7 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Erythema (N = 420, 393, 463) | 31.1 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Fever (N = 421, 394, 463) | 0.9 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Irritability (N = 420, 393, 463) | 2.4 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Vomiting (N = 420, 393, 463) | 9.9 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Fever (N = 421, 394, 463) | 12.3 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Appetite lost (N = 420, 393, 463) | 35.2 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Vomiting (N = 420, 393, 463) | 0.6 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Swelling (N = 420, 393, 463) | 0.6 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-siteTenderness (N = 420, 393, 463) | 1.9 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any Crying abnormal (N = 420, 393, 463) | 39.1 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Swelling (N = 420, 393, 463) | 21.4 Percentage of participants |
Other Pre-specified
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable.
Time frame: Day 0 to Day 7 after the 15 to 18 month vaccination
Population: Solicited reactions were assessed in all subjects who received at least one dose of 15 to 18 month study vaccine, according to the vaccine actually received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Drowsiness (N = 411, 382, 463) | 30.9 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Swelling (N = 411, 382, 463) | 9.2 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Drowsiness (N = 411, 382, 463) | 1.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Appetite lost (N = 411, 382, 463) | 29.7 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Appetite lost (N = 411, 382, 463) | 0.7 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 injection-site Swelling (N=411, 382, 463) | 0.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Irritability (N = 411, 382, 463) | 50.6 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Irritability (N = 411, 382, 463) | 2.7 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Fever (N = 412, 385, 463) | 8.5 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Erythema (N = 411, 382, 463) | 17.8 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Fever (N = 412, 385, 463) | 0.7 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Vomiting (N = 411, 382, 463) | 10.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Tenderness (N = 411, 382, 463) | 37.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Vomiting (N = 411, 382, 463) | 0.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 injection-site Erythema (N=411, 382, 463) | 0.2 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Crying abnormal (N = 411, 382, 463) | 33.8 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Crying abnormal (N = 411, 382, 463) | 1.0 Percentage of participants |
| Menactra Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Tenderness (N = 411, 382, 463) | 0.7 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Tenderness (N = 411, 382, 463) | 54.7 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Drowsiness (N = 411, 382, 463) | 40.6 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Fever (N = 412, 385, 463) | 14.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Crying abnormal (N = 411, 382, 463) | 37.2 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Drowsiness (N = 411, 382, 463) | 1.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Swelling (N = 411, 382, 463) | 19.6 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Vomiting (N = 411, 382, 463) | 0.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Appetite lost (N = 411, 382, 463) | 34.0 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Tenderness (N = 411, 382, 463) | 3.7 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Fever (N = 412, 385, 463) | 1.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Appetite lost (N = 411, 382, 463) | 1.6 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Erythema (N = 411, 382, 463) | 30.1 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 injection-site Erythema (N=411, 382, 463) | 0.8 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Irritability (N = 411, 382, 463) | 57.9 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 injection-site Swelling (N=411, 382, 463) | 0.3 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Vomiting (N = 411, 382, 463) | 7.9 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Irritability (N = 411, 382, 463) | 3.9 Percentage of participants |
| Menactra + Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Crying abnormal (N = 411, 382, 463) | 2.6 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Irritability (N = 411, 382, 463) | 2.4 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Tenderness (N = 411, 382, 463) | 51.4 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 inj.-site Tenderness (N = 411, 382, 463) | 1.9 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Erythema (N = 411, 382, 463) | 31.1 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 injection-site Erythema (N=411, 382, 463) | 1.1 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any injection-site Swelling (N = 411, 382, 463) | 21.4 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 injection-site Swelling (N=411, 382, 463) | 0.6 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Fever (N = 412, 385, 463) | 12.3 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Fever (N = 412, 385, 463) | 0.9 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Vomiting (N = 411, 382, 463) | 9.9 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Vomiting (N = 411, 382, 463) | 0.6 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Crying abnormal (N = 411, 382, 463) | 39.1 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Crying abnormal (N = 411, 382, 463) | 2.2 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Drowsiness (N = 411, 382, 463) | 30.0 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Drowsiness (N = 411, 382, 463) | 1.7 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Appetite lost (N = 411, 382, 463) | 35.2 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Grade 3 Appetite lost (N = 411, 382, 463) | 1.3 Percentage of participants |
| Pentacel Vaccine Group | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine | Any Irritability (N = 411, 382, 463) | 58.5 Percentage of participants |