ong-term follow-up of children who participated at 9-12 months of age in clinical trial PsA-TT-007 in Mali

Not Applicable

Completed

• Conditions: Meningococcal serogroup A; Infections and Infestations

• Registration Number: ISRCTN37623829
• Lead Sponsor: PATH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-19
• Study Completion: 2017-12-01
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 825

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:
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.

Control participants:
1. 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
2. Intent to move out of the study population within the period of study conduct
3. 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric mean titer (GMT) for MenA-specific serum antibody as measured by serum bactericidal antibody assay using rabbit complement (rSBA) approximately four years following primary immunization.