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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Meningococcal Infection; Meningitis

Treatments: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®; Biological: Meningococcal Group C Conjugate vaccine: MenC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359449

MTA73

U1111-1117-7073 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Menactra® Vaccine Group

Experimental group

Description:

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

Treatment:

Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®

Menjugate® Vaccine Group

Active Comparator group

Description:

Meningococcal vaccine naive participants will receive MenC vaccine (Menjugate) given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.

Treatment:

Biological: Meningococcal Group C Conjugate vaccine: MenC