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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Meningitis Meningococcemia Neisseria Meningitidis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Previously received TetraMenD

Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.05 mL, Subcutaneous

Meningococcal vaccine-naїve

Participants have never received a Meningococcal vaccine in the past.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.05 mL, Subcutaneous

Interventions

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

0.05 mL, Subcutaneous

Intervention Type BIOLOGICAL

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

0.05 mL, Subcutaneous

Intervention Type BIOLOGICAL

Other Intervention Names

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Menomune® Menomune®

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes