Clinical trial NCT00772070: Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Official title: Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis
Meningococcemia
Neisseria Meningitidis
Keywords: Menactra®
Menomune®
Meningitis
Meningococcemia
Neisseria meningitidis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 173
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
timeFrame: Day 0 and Days 8 and 28 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
timeFrame: Baseline to Day 8 and Day 28 post-vaccination
measure: Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
timeFrame: Day 0 to 7 post-vaccination
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Woburn
country: United States
state: Massachusetts
city: Bridgeton
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Pichichero M, Papa T, Blatter M, Mitchell D, Kratz R, Sneed J, Bassily E, Casey J, Gilmet G. Immune memory in children previously vaccinated with an experimental quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine. Pediatr Infect Dis J. 2006 Nov;25(11):995-1000. doi: 10.1097/01.inf.0000243215.46312.4a.