Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

Sanofi

Status and phase

Completed

Phase 2

Conditions

Meningitis

Meningococcemia

Treatments

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Haemophilus Influenzae Type b (Hib) vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00771849

MTA15

Details and patient eligibility

About

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.

Primary objective:

To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.

Enrollment

103 patients

Sex

All

Ages

2 to 4 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Participant is healthy, as determined by medical history and physical examination.
Participant is 2 years to < 5 years of age at the time of vaccination.
At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.

Exclusion Criteria :

Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5ºC at the time of inclusion
History of documented invasive meningococcal disease
Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrolment
Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
Received a meningococcal C conjugate vaccine within one year prior to enrolment
Suspected or known hypersensitivity to any of the vaccine 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
Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.