Status:
COMPLETED
Fractional Dose Tetravalent A, C, Y, W135 Meningococcal Polysaccharide Vaccine
Lead Sponsor:
Epicentre
Collaborating Sponsors:
Norwegian Institute of Public Health
University of Oslo
Conditions:
Infections, Meningococcal
Meningitis, Meningococcic
Eligibility:
All Genders
2-20 years
Phase:
PHASE4
Brief Summary
Hypothesis: Lower doses of each A/C/Y/W135 component of the meningococcal polysaccharide vaccine could confer a similar functional immunogenic response as the dose of 50 μg currently being used, and ...
Detailed Description
In 2002, an epidemic of meningococcal disease started in Burkina Faso and Neisseria meningitidis serogroup W135 was identified as the causative organism. This event followed the outbreaks of 2000 and ...
Eligibility Criteria
Inclusion
- Volunteers should not be suffering of severe chronic disease or a known congenital or acquired immunodeficiency. A medical exam will be performed by a medical doctor before inclusion.
- Volunteers must be living in the Mbarara district and within 15 km from the site of immunization. Volunteers should be residents of the chosen site and should express no plan of moving from this area during the study period.
- Volunteers must be available for follow-up for the duration of the study (minimum of 24 months).
Exclusion
- Volunteers with severe chronic disease or with a general condition requiring hospital admission.
- Volunteers with a known congenital or acquired immunodeficiency (e.g. HIV). Diagnosis will be presumptive based on the medical background and the clinical examination. No serological HIV testing will be performed.
- Evidence of any concomitant infection at the time of presentation (including rashes other than scabies; ear, nose or throat infections; and abnormal respiratory system examination).
- The patient has any other underlying diseases that compromise the diagnosis and the evaluation of the response to the study medication.
- History of serious adverse reactions to vaccines such as anaphylaxis or related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain.
- Malnutrition: The nutritional assessment of children aged 24-59 months, a weight-for-height (W/H) index, will be calculated. This index is expressed in standard deviations of a normalised distribution of a reference population 38 (National Centre for Health Statistics, USA). Children under 5 years old with a Z-score inferior to -2 will be excluded. For children over 5 or adults, the clinical examination will be considered.
- Pregnant women and lactating women are not eligible for this trial. All women of child-bearing age must provide a urine sample for pregnancy testing before inclusion and, for sub-group "b", before the second vaccine injection.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT00271479
Start Date
June 1 2004
End Date
November 1 2006
Last Update
December 22 2006
Active Locations (2)
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1
Norwegian Institute of Public Health
Oslo, Norway
2
Mbarara Epicentre Research Base
Mbarara, Uganda