Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Immunogenicity of Two Doses of Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) or One Dose of Monovalent Meningococcal Group C Conjugate Vaccine Administered Concomitantly With Routine Immunizations Between 12 and 18 Months of Age in Canada

Conditions
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Meningitis, Meningococcal Infection

Intervention / Treatment
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* Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
* Biological: Meningococcal Group C Conjugate vaccine: MenC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menactra® Vaccine Group<br>Meningococcal vaccine naive participants will receive Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) at 12 months of age and at 18 months of age concomitantly with routine vaccines administered as per provincial schedule | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Active Comparator: Menjugate® Vaccine Group<br>Meningococcal vaccine naive participants will receive MenC vaccine (Menjugate) given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. | Biological: Meningococcal Group C Conjugate vaccine: MenC<br>* 0.5 mL, Intramuscular<br>* Other names: MenC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days post-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. | 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 | 28 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days post-vaccination | 
| 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 | 28 days post-vaccination | 
| 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 | 28 days post-vaccination | 
| 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 | 28 days post-vaccination | 
| 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. | Day 0 up to Day 7 post-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 | 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. | Day 0 up to Day 7 post-vaccination | 
| 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 | Day 0 up to Day 7 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcal Infection, Menactra®, MenC