Clinical trial NCT02551627: A Study to Investigate the Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children
Official title: Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children (7-10yrs; Inclusive) in Bangladesh: a Randomised, Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Growth and Development
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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
* Previous participation in this study, in another clinical study or receipt of an investigational drug within 30 days of screening visit; participation in any nutritional study or didactic nutritional education in last 6 months of the screening visit

Primary outcomes:
measure: Vaccine response test
timeFrame: 18 weeks
Secondary outcomes:
measure: Absolute vibriocidal antibody titer
timeFrame: 18 weeks
measure: Change from baseline in nutrional biochemistry
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: