Last updated: 11/03/2018 22:33:39
A Study to investigate the impact of a multiple micronutrient (MMN) beverage powder on vaccine response in school children
GSK study ID
204476
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Vaccine response test
Timeframe: 18 weeks
Secondary outcomes:
Absolute vibriocidal antibody titer
Timeframe: 18 weeks
Change from baseline in nutrional biochemistry
Timeframe: 18 weeks
Interventions:
Dietary supplement: Test Product
Dietary supplement: Control
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2017-08-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Growth and Development
Product
GSK3129091
Collaborators
Not applicable
Study date(s)
October 2016 to June 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
7 - 10 years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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