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This will be a double blind, two-arm, parallel-group, stratified for gender, randomised, controlled study in participants aged 7-10 years (yrs). The aim of the study is to test the hypothesis that MMN fortified beverage may help improve immunity outcomes as assessed through vaccine response in 7-10 yrs old school participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | MMN fortified beverage powder [27 gram (g)] made up in 150 milliliter (mL) of water, will be administered orally as a single serve, twice daily for 18 weeks. |
|
| Control | Active Comparator | Isocaloric beverage powder without micronutrient fortification (27 g), made up in 150 mL of water will be administered orally as a single serve, twice daily for 18 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product | Dietary Supplement | MMN fortified beverage powder. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine response test | Proportion of participants demonstrating vaccine reponse, receiving either test product or control will be determined and compared. Vaccine response will be defined as greater than or equal to 4 fold increase from pre-vaccine visit in vibriocidal antibody response 7 days post second vaccine dose. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute vibriocidal antibody titer | Blood will be drawn by qualified study personnel as per visits and antibody levels will be assessed. | 18 weeks |
| Change from baseline in nutrional biochemistry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| Control |
| Dietary Supplement |
Isocaloric beverage powder without micronutrient fortification. |
|
Change in nutritional biochemistry for micronutrients vitamins A, B6, B12, C, D, E, folate and of the trace elements (selenium, zinc, copper, iron), ferritin, serum transferrin receptor (sTfR), C-reactive protein (CRP), alpha 1-acid glycoprotein (AGP) from baseline to end of the intervention will be measured from the drawn blood.
| 18 weeks |