An interventional study of Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax and Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices in Immunization Coverage, Vaccination and Nutrition, sponsored by Alliance for International Medical Action. Completed at 1 site in Nigeria. Open to participants aged 6 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Alliance for International Medical Action · Not applicable, Interventional, and Prevention
Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services.
The investigators will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the end line cross-sectional household survey, 2) in children aged 6-12 months at inclusion, in a longitudinal 12 months follow-up survey.
Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of the
This study will be implemented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria.
This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and end line cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized subsample of health facilities.
Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm:
Background/ Rational
Every year, hundreds of thousands of children are treated for severe wasting while experiencing repeated and prolonged outbreaks of vaccine-preventable illnesses, most notably measles. At least 20 million children annually still do not receive immunizations. Northeast Nigeria is at the epicentre of this dynamic, recording some of the worst malnutrition indicators and lowest vaccination coverage rates in the world.
Small-quantity lipid-based nutrient supplements (SQ-LNS) are a class of ready-to-use food supplements which are highly nutrient-dense and fortified designed for preventing malnutrition and improving child survival, growth, and development. A recent meta-analysis on SQ-LNS reveals that feeding a child just one sachet of SQ-LNS a day for a year can reduce their risk of mortality by 27%, and reduce cases of severe wasting by 31% and severe stunting by 17%. The overall strength of evidence on SQ-LNS benefits led the authors of a 2021 Lancet review to call scaling-up SQ-LNS a priority action.
Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services.
Primary objective
To estimate the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, in children aged 12-23 months in the end line cross-sectional household survey.
Main secondary objective
To estimate the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, in children aged 6-12 months at inclusion in the longitudinal 12 months follow-up survey.
Secondary objectives
Study sites : 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria
Study design
A pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and end line cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized subsample of health facilities.
Interventions compared
The unit of randomization (cluster) will be the ward and its catchment area. Clusters will be randomly allocated at a ratio of 1:1 either to the standard EPI arm or to the NutriVax arm.
Statistical analyses
Differences in measles vaccine coverage (dose 1) between control and intervention arms at end line will be assessed using multilevel regression models.
The study will be conducted in compliance with the protocol, the Declaration of Helsinki, the GCP guidelines and the Nigerian National Code for Health Research Ethics
Timeline : 2 years (December 2023-December 2025)
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 3,814 is above the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Alliance for International Medical Action is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Baseline and endline cross-sectional household surveys Inclusion criteria
Longitudinal follow-up survey Inclusion criteria
Qualitative feasibility and acceptability survey Inclusion
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts.
Behavioral: Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices
The NutriVax strategy combines the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres for children 6-23 months of age.
Dietary Supplement: Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax · Behavioral: Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices
1. The SQ-LNS distribution program will be implemented for 12 consecutive months in the NutriVax arm. 2. Community mobilizers in the NutriVax arm will give information in the community about SQ-LNS and eligibility criteria for SQ-LNS distributions. 3. All SQ-LNS distributions will take place at the primary health care center (PHCC) of each ward. 4. Children aged 6-22m, residing in settlements of the catchment area of the NutriVax arm are eligible for a monthly ration of SQ-LNS (28 sachets per month) following a check and update of his or her vaccine status at PHCC; unless there are serious issues related to access to PHCC, in which cases ration sizes may be revised upwards to three months' worth. 5. All children will exit the SQ-LNS distribution program when they are 23 months of age OR after receiving a maximum of 12 consecutive monthly rations, whichever comes first. 6. The total amount of SQ-LNS a child receives will depend on when they enroll in the SQ-LNS distribution program.
1. Parents or guardian of children will be encouraged/sensitised to attend their scheduled preventive visits to receive other essential paediatric services; 2. Sensitization on vaccination and recommended Infant and Young Child Feeding (IYCF) practices including the need to consume a diverse nutritious diet and support for continued breastfeeding will be conducted according to the Ministry of Health's routine plans in the community and at primary health care centres; 3. Community mobilizers will promote the importance of vaccinations according to the Expanded Program on Immunization (EPI) as well as IYCF good practices messages.
Measles vaccine coverage in children aged 12-23 months
The proportion of children aged 12-23 months in the endline survey who have received at least one dose of measles vaccine, as reported on their vaccination card.
Time frame: Measured after one year after of intervention implementation.
Measles vaccine coverage in children 6-12 months at inclusion
The proportion of children aged 6-12 months at inclusion in the longitudinal follow-up survey, who have received at least one additional dose of measles vaccine, as reported on their vaccination card, administered between inclusion and the end of follow-up.
Time frame: Measured after one year after of intervention implementation.
Measles vaccine coverage: at least one dose
The proportion of children with at least one measles vaccine as reported on a vaccination card or by recall.
Time frame: Measured after one year after of intervention implementation.
Measles vaccine coverage : two doses
The proportion of children with a measles 2 vaccine as reported on a vaccination card or by recall
Time frame: Measured after one year after of intervention implementation.
Timeliness of measles 1 vaccination
Proportion of children with Measles 1 vaccine received within 30 days of turning 9 months by card
Time frame: Measured after one year after of intervention implementation.
Other infant vaccines coverage
Proportion of children with Pentavalent 1 and 3, yellow fever, meningitis vaccine as reported on a vaccination card or by recall
Time frame: Measured after one year after of intervention implementation.
Zero-dose
Proportion of children with No measles + pentavalent + yellow fever + meningitis vaccines reported on a vaccination card or by recall.
Time frame: Measured after one year after of intervention implementation.
Fully immunization
Proportion of children who had received all childhood vaccinations recommended by the Nigeria MOH.
Time frame: Measured after one year after of intervention implementation.
Acceptability
Barriers and facilitators to access health care centres and receive SQ-LNS mass supplementation implemented as a routine preventive program nested in health facilities activities
Time frame: Measured after 2 months and one year after of intervention implementation.
Cost-efficiency
• Cost per child vaccinated and supplemented compared to cost per child vaccinated only, using a facility and caregiver perspectiveto identify all provider and caregiver costs associated with treatment.
Time frame: Measured after one year after of intervention implementation.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Possible data sharing agreement, possible one year after publication of the main results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Before (protocol, ICF) and during data collection (SAP)
Access criteria: Protocol, ICF and SAP on clinicaltrials.gov
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Alliance for International Medical Action