Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

Sanofi

Status and phase: Completed; Phase 4

Conditions: Meningitis; Diphtheria; Tetanus; Pertussis; Meningococcemia

Treatments: Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.; Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap; Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777257

MTA21

Details and patient eligibility

About

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

Primary Objective:

To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.

Secondary Objective:

To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.

Enrollment: 1,345 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Healthy as determined by medical history and physical examination.
• Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
• Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
• Informed assent form that has been approved by the IRB signed by the subject.
• Subject (female) agrees to use measures to prevent pregnancy during the study.

Exclusion Criteria :

• Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
• Known or suspected impairment of immunologic function.
• Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
• History of documented invasive meningococcal disease or previous meningococcal vaccination.
• History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
• Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting <7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
• Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
• Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
• Suspected or known hypersensitivity to either of the two study vaccines or their components.
• Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
• Enrolled in another clinical trial.
• Diagnosed with 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.
• For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
• Nursing mothers.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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1,345 participants in 3 patient groups

Study Group A

Experimental group

Description:

Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later

Treatment:

Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.

Study Group B

Experimental group

Description:

Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later

Treatment:

Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.

Study Group C

Experimental group

Description:

Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later

Treatment:

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap