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This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.
This non-interventional long-term follow-up study will involve one telephonic contact in all 1800 former participants from study ACYWX-03 followed by one visit beyond five years after vaccination in a subset of 450 participants. This subset will be randomly selected to participate in a follow-on immune persistence evaluation. To document the duration of the immune response and any requirement of booster dose in the target population, this study is intended to explore antibody persistence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NmCV-5 | |||
| MenACWY-D |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X | five-six years after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with rSBA titers ≥ 8 | five-six years after vaccination. | |
| Percentage of participants with rSBA titers ≥ 128 | five-six years after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Participants from the previous study ACYWX-03 conducted at the Gambia and Mali
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Prasad Kulkarni, MD, FRCP | Contact | +91-20-71946820 | drpsk@seruminstitute.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251 Bamako, Mali BP251 | Recruiting | Bamako | Mali |
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Serum
| Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Fajara, The Gambia | Recruiting | Banjul | The Gambia |
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