A Study to Investigate the Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Re… (NCT02551627) | Clinical Trial Compass
WithdrawnNot Applicable
A Study to Investigate the Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children
0Started 2016-06-01
Plain-language summary
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.
Who can participate
Age range7 Years – 10 Years
SexALL
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Inclusion Criteria:
* Understanding and willingness to participate in the study as demonstrated by participants' parents and/or Legally acceptable representatives (LARs) voluntary written informed consent, participants' written assent
* Participants aged between 7-10 yrs, inclusive
* Good general and mental health
* Participants with Z-scores of BMI for age of ≥-3 to ≤+1
Exclusion Criteria:
* Children in Care (CiC)
* Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
* Participant who has already been administered cholera vaccine in any form prior to this study and any known contra-indication to oral cholera vaccine
* Participant who consumed any antibiotics during the week prior to the first dose of study vaccination until the end of the study
* Severe anemia (Hb \< 8 g/dL), recent history (2 months) of serious infections, injuries and/or surgeries
* Participant consuming nutritional supplement and/or health food drinks on regular basis (≥ 3 times a week) in last 3 months
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder
* Participants likely to move out of geographical range of the study within study duration
* Child of an employee of the sponsor or the study site or members of their immediate family, sibling of participant already enrolled in the study
* Prev…