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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningitis Meningococcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Menactra® Vaccine Group

Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine

Group Type EXPERIMENTAL

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Hiberix® Vaccine Group

Participants receiving Haemophilus Influenzae Type b (Hib) vaccine

Group Type ACTIVE_COMPARATOR

Haemophilus Influenzae Type b (Hib) vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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Haemophilus Influenzae Type b (Hib) vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Menactra® Hiberix®

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes