Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine

Sanofi

Status and phase

Completed

Phase 2

Conditions

Meningitis

Meningococcemia

Neisseria Meningitidis

Treatments

Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00772070

MTA17

Details and patient eligibility

About

This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.

Primary Objective:

To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.

Full description

This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.

Enrollment

173 patients

Sex

All

Ages

3 to 5 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Stage I
Participant is healthy, as determined by medical history and physical examination.
Participant is at least 3 years of age but not yet 6 years of age at the enrolment.
For the TetraMenD group: received one dose of TetraMenD as a participant in trial 603-02 no less than 18 months prior to enrolment
For the Control group: no previous history of any meningococcal vaccination
Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
Stage II
Participant is healthy, as determined by medical history and physical examination.
Participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in Stage 1.
Enrolled in the Control group only and received one dose of the reduced dose Menomune at Stage 1.
Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.

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 axillary temperature (≥ 99.5ºF [≥ 37.5ºC]) at the time of inclusion
For Stage I, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from Trial 603-02.
For Stage II, history of documented invasive meningococcal disease or participant did not receive Reduced-dose Menomune® six months prior.
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 enrollment.
Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn
Received any vaccine in the 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in Stage 1 of the trial.
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.