Dose Comparison Study of Menactra® in US Children

Sanofi

Status and phase: Completed; Phase 2

Conditions: Meningococcal Infection; Meningitis; Neisseria Meningitidis

Treatments: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700635

MTA61

Details and patient eligibility

About

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.

Primary Objective:

To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Full description

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Enrollment: 333 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Aged 2 to < 11 years on the day of inclusion.
• Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
• Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
• Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
• Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
• Receipt of blood or blood-derived products in the past 3 months.
• Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.
• Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
• Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
• History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
• Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
• Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
• Personal or family history of Guillain-Barré Syndrome (GBS).
• Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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333 participants in 3 patient groups

Menactra® Group 1

Experimental group

Description:

Participants aged 2 to \< 4 years

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Menactra® Group 2

Experimental group

Description:

Participants aged 4 to \< 6 years

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Menactra® Group 3

Active Comparator group

Description:

Participants aged 6 to \< 11 years

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate