Meningitis, Meningococcal Infection
Conditions
Keywords
Meningitis, Meningococcal Infection, Menactra®, MenC
Brief summary
The purpose for this study is to demonstrate the safety and immunogenicity of two doses of Menactra® administered between 12 and 18 months of age and concomitantly with routine immunization with two different provincial schedule Primary Objectives: * To describe the immunogenicity of Menactra® administered concomitantly with routine immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants (measured by serum bactericidal assay using baby rabbit complement \[SBA-BR\]) * To describe the immunogenicity of MenC administered concomitantly with routine immunizations at 12 months of age (measured by SBA-BR) Secondary Objectives: Safety * To describe the safety profile of Menactra® and MenC vaccines after each dose when given concomitantly with routine immunization. Immunogenicity * To describe the immunogenicity of both vaccines using serum bactericidal assay using human complement \[SBA-HC\] * To describe the immunogenicity of Pediacel administered at 18 months.
Detailed description
Participants depending on their groups will receive either two doses of Menactra vaccine concomitantly with the routinely recommended vaccines or one dose of MenC vaccine concomitantly with the routinely recommended vaccines and will be monitored for safety and immunogenicity. The duration of each subject's participation in the trial will be approximately 7 months.
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
0.5 mL, Intramuscular
BIOLOGICALMeningococcal Group C Conjugate vaccine: MenC
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
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 12 months (365 to 400 days) on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Informed consent form has been signed and dated by the parent(s) or other legally authorized representative * Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures * Group 1: Subject has received 3 primary vaccination doses of Pediacel as per routine immunization schedule * Group 3: Subject has received two doses of MenC vaccine at approximately 2 and 4 months of age as per Alberta immunization schedule.
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination(s), which may be received at least two weeks before study vaccines * Planned receipt of any vaccine in the 4 weeks following any trial vaccination * Previous vaccination against Meningococcal disease OR * Subject has previously received only one dose of MenC vaccine, or more than two doses of MenC vaccine, or two doses of MenC vaccine with the most recent dose received in the past 6 months * Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response * 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) * Personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the parent/legal representative * History of documented invasive meningococcal disease * At high risk for meningococcal disease during the trial * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * History of contraindication to receipt of pertussis-containing vaccine * Thrombocytopenia, as reported by the parent/legal representative, contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * History of seizures * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * History of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | 28 days post-vaccination | Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination |
| Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | 28 days post-vaccination | Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | 28 days post-vaccination | Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group |
| Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | 28 days post-vaccination | Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers \< 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate |
| Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | 28 days post-vaccination | Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination. |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Day 0 up to Day 7 post-vaccination | Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, 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; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable. |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Day 0 up to Day 7 post-vaccination | Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Day 0 up to Day 7 post-vaccination | Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, 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; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable. |
| Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | 28 days post-vaccination | Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination |
Countries
Canada
Participant flow
Recruitment details
Study participants were enrolled from 19 May 2011 through 14 September 2011 in one clinic site in Canada.
Pre-assignment details
A total of 123 participants that met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Menactra® Vaccine Group Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age) | 61 |
| Menjugate® Vaccine Group Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. | 62 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Menjugate® Vaccine Group | Menactra® Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 62 Participants | 61 Participants | 123 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.4 Months STANDARD_DEVIATION 0.3 | 12.4 Months STANDARD_DEVIATION 0.3 | 12.4 Months STANDARD_DEVIATION 0.3 |
| Region of Enrollment Canada | 62 Participants | 61 Participants | 123 Participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 29 Participants | 27 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 50 / 61 | 40 / 62 |
| serious Total, serious adverse events | 1 / 61 | 2 / 62 |
Outcome results
Primary
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Time frame: 28 days post-vaccination
Population: Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age13 months, N = 0, 60) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months, N = 51, 58) | 1740 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months, N = 0, 60) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months, N = 51, 58) | 957 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months, N = 0, 60) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months, N = 51, 58) | 719 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months, N = 0, 60) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months, N = 51, 58) | 970 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months, N = 51, 58) | 7.36 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age13 months, N = 0, 60) | 4.34 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months, N = 0, 60) | 31.3 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months, N = 51, 58) | 4.35 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months, N = 0, 60) | 5.28 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months, N = 0, 60) | 71.0 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months, N = 51, 58) | 67.1 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months, N = 51, 58) | 11.0 Titers |
Primary
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Time frame: 28 days post-vaccination
Population: Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 13 months; N = 0, 60) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months; N = 51, 58) | 51 Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months; N = 0, 60) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months; N = 51, 58) | 49 Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months; N = 0, 60) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months; N = 51, 58) | 51 Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months; N = 0, 60) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months; N = 51, 58) | 50 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months; N = 51, 58) | 11 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 13 months; N = 0, 60) | 1 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months; N = 0, 60) | 36 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months; N = 51, 58) | 2 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months; N = 0, 60) | 5 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months; N = 0, 60) | 40 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months; N = 51, 58) | 39 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months; N = 51, 58) | 15 Participants |
Secondary
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group
Time frame: 28 days post-vaccination
Population: Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Diphtheria (at age 18 months; N = 46, 0) | 0.420 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Diphtheria (at age 19 months; N = 46, 0) | 7.81 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Tetanus (at age 18 months; N = 44, 0) | 0.485 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Tetanus (at age 19 months; N = 47, 0) | 8.71 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | PRP (at age 18 months; N = 44, 0) | 0.500 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | PRP (at age 19 months; N = 46, 0) | 46.3 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 1 (at age 18 months; N = 45, 0) | 138 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 1 (at age 19 months; N = 46, 0) | 4552 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 2 (at age 18 months; N = 39, 0) | 203 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 2 (at age 19 months; N = 46, 0) | 6889 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 3 (at age 18 months; N = 38, 0) | 133 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 3 (at age 19 months; N = 45, 0) | 5322 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertussis Toxoid (at age 18 months; N = 45, 0) | 8.61 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertussis Toxoid (at age 19 months; N = 47, 0) | 162 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Filamentous hemagglutinin (age 18 months; N=45, 0) | 19.9 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Filamentous hemagglutinin (age 19 months; N=47, 0) | 239 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertactin (at age 18 months; N = 44, 0) | 8.45 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertactin (at age 19 months; N = 45, 0) | 123 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Fimbriae types 2 and 3 (age 18 months; N = 45, 0) | 35.7 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Fimbriae types 2 and 3 (age 19 months; N = 45, 0) | 622 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertactin (at age 19 months; N = 45, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Diphtheria (at age 18 months; N = 46, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 3 (at age 18 months; N = 38, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Diphtheria (at age 19 months; N = 46, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Filamentous hemagglutinin (age 19 months; N=47, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Tetanus (at age 18 months; N = 44, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 3 (at age 19 months; N = 45, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Tetanus (at age 19 months; N = 47, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Fimbriae types 2 and 3 (age 19 months; N = 45, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | PRP (at age 18 months; N = 44, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertussis Toxoid (at age 18 months; N = 45, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | PRP (at age 19 months; N = 46, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertactin (at age 18 months; N = 44, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 1 (at age 18 months; N = 45, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Pertussis Toxoid (at age 19 months; N = 47, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 1 (at age 19 months; N = 46, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Fimbriae types 2 and 3 (age 18 months; N = 45, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 2 (at age 18 months; N = 39, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Filamentous hemagglutinin (age 18 months; N=45, 0) | NA Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age. | Polio Type 2 (at age 19 months; N = 46, 0) | NA Titers |
Secondary
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.
Time frame: 28 days post-vaccination
Population: Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 13 months, N = 0, 44) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months, N = 0, 45) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months, N = 0, 50) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months, N = 49, 53) | 299 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months, N = 49, 48) | 71.7 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months, N = 0, 45) | NA Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months, N = 49, 53) | 219 Titers |
| Menactra® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months, N = 49, 50) | 207 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months, N = 49, 50) | 2.17 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 13 months, N = 0, 44) | 2.23 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months, N = 49, 48) | 2.21 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months, N = 0, 50) | 17.4 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months, N = 49, 53) | 6.93 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months, N = 0, 45) | 2.00 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months, N = 49, 53) | 2.14 Titers |
| Menjugate® Vaccine Group | Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months, N = 0, 45) | 2.06 Titers |
Secondary
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any injection site Erythema | 32 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Crying abnormal | 31 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Fever | 44 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Drowsiness | 31 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any injection site Swelling | 18 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Appetite lost | 45 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Vomiting | 10 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Irritability | 50 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any injection site Tenderness | 36 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Irritability | 40 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any injection site Tenderness | 21 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any injection site Erythema | 23 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any injection site Swelling | 8 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Fever | 18 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Vomiting | 7 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Crying abnormal | 22 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Drowsiness | 12 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination | Any Appetite lost | 24 Participants |
Secondary
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, 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; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any injection site Tenderness | 30 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 injection site Tenderness | 2 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any injection site Erythema | 19 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 injection site Erythema | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any injection site Swelling | 11 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 injection site Swelling | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Fever | 21 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Fever | 3 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Vomiting | 6 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Vomiting | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Crying abnormal | 25 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Crying abnormal | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Drowsiness | 20 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Drowsiness | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Appetite lost | 32 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Appetite lost | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Irritability | 40 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Irritability | 2 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Drowsiness | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any injection site Tenderness | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Vomiting | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 injection site Tenderness | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Irritability | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any injection site Erythema | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Crying abnormal | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 injection site Erythema | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Appetite lost | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any injection site Swelling | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Crying abnormal | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 injection site Swelling | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Irritability | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Fever | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Drowsiness | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Fever | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Grade 3 Appetite lost | NA Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age | Any Vomiting | NA Participants |
Secondary
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, 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; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any injection site Tenderness | 21 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 injection site Tenderness | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any injection site Erythema | 26 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 injection site Erythema | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any injection site Swelling | 9 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 injection site Swelling | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Fever | 30 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Fever | 1 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Vomiting | 5 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Vomiting | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Crying abnormal | 25 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Crying abnormal | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Drowsiness | 22 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Drowsiness | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Appetite lost | 28 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Appetite lost | 0 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Irritability | 43 Participants |
| Menactra® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Irritability | 1 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Drowsiness | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any injection site Tenderness | 21 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Vomiting | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 injection site Tenderness | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Irritability | 1 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any injection site Erythema | 23 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Crying abnormal | 22 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 injection site Erythema | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Appetite lost | 24 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any injection site Swelling | 8 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Crying abnormal | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 injection site Swelling | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Irritability | 40 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Fever | 18 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Drowsiness | 12 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Fever | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Grade 3 Appetite lost | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age | Any Vomiting | 7 Participants |
Secondary
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination
Time frame: 28 days post-vaccination
Population: Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 13 months; N = 0, 44) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months; N = 49, 48) | 48 Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months; N = 0, 50) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months; N = 49, 53) | 49 Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months; N = 0, 45) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months; N = 49, 53) | 49 Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months; N = 0, 45) | NA Participants |
| Menactra® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months; N = 49, 50) | 48 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 19 months; N = 49, 50) | 1 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 13 months; N = 0, 44) | 1 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 13 months; N = 0, 45) | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup A (at age 19 months; N = 49, 48) | 1 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup W-135 (at age 13 months; N = 0, 45) | 0 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 13 months; N = 0, 50) | 39 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup Y (at age 19 months; N = 49, 53) | 2 Participants |
| Menjugate® Vaccine Group | Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age. | Serogroup C (at age 19 months; N = 49, 53) | 21 Participants |
Secondary
Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)
Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers \< 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate
Time frame: 28 days post-vaccination
Population: Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menactra® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Pertussis toxoid (N = 44, 0) | 44 Participants |
| Menactra® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Filamentous hemagglutinin (N = 44, 0) | 43 Participants |
| Menactra® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Pertactin (N = 41, 0) | 38 Participants |
| Menactra® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Fimbriae types 2 and 3 (N = 42, 0) | 42 Participants |
| Menjugate® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Fimbriae types 2 and 3 (N = 42, 0) | NA Participants |
| Menjugate® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Pertussis toxoid (N = 44, 0) | NA Participants |
| Menjugate® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Pertactin (N = 41, 0) | NA Participants |
| Menjugate® Vaccine Group | Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group) | Filamentous hemagglutinin (N = 44, 0) | NA Participants |