| 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 | Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 days post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| Serogroup A (at age13 months, N = 0, 60) | | | Title | Measurements |
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| - OG000NA(NA to NA)Data not determined for this group at this time point as per protocol.
- OG0014.34(3.69 to 5.10)
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| | Serogroup A (at age 19 months, N = 51, 58) | | |
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| 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 | Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population | Posted | | Number | | Participants | | 28 days post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| 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. | Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 days post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| 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 | Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population | Posted | | Number | | Participants | | 28 days post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| 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 | Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 days post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| 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 | Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group | Posted | | Number | | Participants | | 28 days post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| 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. | Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population | Posted | | Number | | Participants | | Day 0 up to Day 7 post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| 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. | Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population | Posted | | Number | | Participants | | Day 0 up to Day 7 post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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| 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 | Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population | Posted | | Number | | Participants | | Day 0 up to Day 7 post-vaccination | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | Menjugate® Vaccine Group | Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. |
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