ISRCTN37623829
Completed
N/A
A Phase IV, open-label, controlled study to evaluate the up-to-four-year antibody persistence among Malian children who previously received different doses and schedules of meningococcal conjugate group A vaccine (PsA-TT 5µg or 10µg) between 9 and 18 months of age and to assess the boosting effect following a catch-up campaign dose of MenAfriVac® (PsA-TT 10µg)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Meningococcal serogroup A
- Sponsor
- PATH
- Enrollment
- 825
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Former Study PsA\-TT\-007 participants:
- •1\. Received study vaccine (PsA\-TT 5µg or 10µg)
- •2\. Final evaluable blood collection must have been completed within 3 months after the second vaccination
- •3\. Younger than 6 years of age as of March 1st, 2017
- •4\. Written informed consent obtained from the participants’ parent(s) or guardian following international ethical guidelines for epidemiological studies and applicable local ethical guidance and requirements (added 27/02/2017\)
- •Control participants:
- •1\. Born between March 2011 and March 2012
- •2\. No evidence of chronic disease
- •3\. Younger than 6 years of age as of March 1st, 2017
- •4\. Written informed consent obtained from the participants’ parent(s) or guardian following international ethical guidelines for epidemiological studies and applicable local ethical guidance and requirements (added 27/02/2017\)
Exclusion Criteria
- •Exclusion criteria as of 27/02/2017:
- •1\. Received meningococcal vaccination outside the PsA\-TT\-007 study (all participants, conjugate or polysaccharide)
- •2\. Any chronic condition or medical/hereditary history suggesting participant would be immunocompromised (i.e. primary immunodeficiency, HIV, autoimmune disease)
- •3\. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune\-modifying agents within the past three months (including systemic or inhaled corticosteroids, this means prednisone or equivalent, \=0\.5 mg/kg/day; topical steroids are allowed)
- •4\. Administration of immunoglobulins and/or any blood products within the last 90 days.
- •5\. Residence outside the study area for any prolonged period since birth (at the discretion of the PI) such that the potential for exposure to circulating N. meningitidis serogroup A may differ from the rest of the population (control participants only)
- •6\. Intent to move out of the study population within the period of study conduct
- •7\. Any condition or criteria that in the opinion of the investigator might compromise the well\-being of the participant or compliance with study procedures or interfere with the outcome of the study
- •Original exclusion criteria:
- •Former Study PsA\-TT\-007 participants:
Outcomes
Primary Outcomes
Not specified
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