Immunization CoverageNCT06387511
Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months
A study testing Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax and Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices in people with Immunization Coverage and Vaccination, run by Alliance for International Medical Action at 1 site in Nigeria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunization Coverage, Vaccination, Nutrition
- What is being tested?
- Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax and Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,814 participants
- Where
- 1 siteNigeria
- Study dates
- 7 May 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
- Baseline and endline cross-sectional household surveys Inclusion criteria
- Aged 12-23 months;
- With oral informed consent of parent or legal guardian;
- Residing in the catchment settlements of wards included in the study. Exclusion criteria
- Included in the longitudinal follow-up.
- Longitudinal follow-up survey Inclusion criteria
- Aged 6-12 months;
- With written informed consent of parent or legal guardian;
- Residing in the catchment settlements of wards included in the study. Exclusion criteria
- Acute malnutrition criteria as per the WHO definition (i.e. MUAC< 125 or WHZ < -2 or nutritional edema);
- - Known medical complication that requires referral for hospitalization;
- Known allergies to SQ-LNS or SQ-LNS contraindication;
- Any other condition interfering with protocol adherence or the ability to give informed consent, in the judgment of the Field Investigator Sampling for HHS and LS will be carried out in three stages in each LGA using probability proportional to size (PPS).
- Qualitative feasibility and acceptability survey Inclusion
- Parent or legal guardian of a child aged 6-23 months and residing in the catchment settlements of wards included in the study, or Health worker of the ministry of health involved in the study,or Community representative or Community health workers;
- With written informed consent.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
All Primary Health Care Centers of Nguru and Karasuwa LGAs
Damaturu, Yobe State
About this study
Official title: NutriVax-Measles: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months, a Pragmatic Parallel Cluster-randomized Controlled Trial in Yobe State, Northern Nigeria
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.
Read more
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:
- 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, named the standard EPI arm;
- The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm.
Read the detailed description
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
- To estimate the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in children aged 6-23 months, after 12 months of program implementation, in terms of 1) all other infant vaccines' uptake, 2) timeliness of age-eligible vaccinations; 3) anthropometric status, 4) uptake of paediatric curative and preventive health consultations and activities.
- To assess the barriers and facilitators to SQ-LNS mass supplementation implemented as part of a routine immunization program in health facilities, from the perspectives of parents/legal guardian of children aged 6-23 months, health care providers and community health workers.
- To assess the cost-efficiency of a SQ-LNS mass supplementation program compared to routine immunization program in terms of cost per child supplemented and vaccinated.
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 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, named the standard EPI arm.
- The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm.
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)
- Conditions
- Immunization Coverage, Vaccination, Nutrition
- Being tested
- Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax, Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices
- Keywords
- Vaccination coverage, Incentives, Small quantity of Lipid Based Nutrients (SQ-LNS), Measles, Cost-effectiveness, Acceptability, Child, Africa, Nigeria, Malnutrition, prevention
- Medical subject headings
- Measles, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVaxDietary supplement
- The SQ-LNS distribution program will be implemented for 12 consecutive months in the NutriVax arm.
- Community mobilizers in the NutriVax arm will give information in the community about SQ-LNS and eligibility criteria for SQ-LNS distributions.
- All SQ-LNS distributions will take place at the primary health care center (PHCC) of each ward.
- 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.
- 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.
- The total amount of SQ-LNS a child receives will depend on when they enroll in the SQ-LNS distribution program.
Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practicesBehavioural
- Parents or guardian of children will be encouraged/sensitised to attend their scheduled preventive visits to receive other essential paediatric services;
- 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;
- Community mobilizers will promote the importance of vaccinations according to the Expanded Program on Immunization (EPI) as well as IYCF good practices messages.
| Study group | Role | What they receive |
|---|---|---|
| Standard Expanded program on immunization | Active comparator | 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. Receives: Behavioral: Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices |
| NutriVax | Experimental | 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. Receives: Dietary Supplement: Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax; Behavioral: Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measured after one year after of intervention implementation.
Secondary outcomes (8)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Measured after one year after of intervention implementation.
Fully immunization
Proportion of children who had received all childhood vaccinations recommended by the Nigeria MOH.
Measured: 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
Measured: 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.
Measured: Measured after one year after of intervention implementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start7 May 2024
- Primary completion26 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immunization CoverageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two arms superiority opened pragmatic parallel cluster-randomized controlled trial with baseline measure
- Masking
- None (open label)
- Enrolment
- 3,814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Yobe State Primary Health Care Board, Nigeria, Eleanor Crook Foundation, ECF, Gavi, The Vaccine Alliance
- Responsible party
- Sponsor
- Investigators
- Renaud Becquet, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387511
- Sponsor's protocol ID
- NutriVax-Measles
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Possible data sharing agreement, possible one year after publication of the main results.
Publications
Cazes C, Goni BW, Gabillard D, Owolabi O, Yapi B, Nabunje J, Atanga I, Akinyi AM, Danho S, Balestre E, Badje A, Idriss F, Kasim M, Audu Bukarti MM, Emeka CU, Chouinard M, Mushenvula JP, Bahonan S, Plazy M, Abdoulaye O, Chiroma U, Adam HM, Montfort C, Muhammad NS, Becquet R, Phelan KPQ. Small quantity lipid-based nutritional supplementation and measles vaccination coverage in children aged 6-23 months: a pragmatic cluster-randomized trial. Nat Med. 2026 Oct 2. doi: 10.1038/s41591-026-04675-1. Online ahead of print.
PubMed 42827131Cazes C, Goni BW, Muhammad NS, Gabillard D, Balonda PK, Feuzeu L, Atanga I, Yapi B, Habiyambere GG, Danho S, Balestre E, Adams KP, Plazy M, Phelan KPQ, Becquet R. Increasing measles vaccination coverage through supplementation with an SQ-LNS incentive in children aged 6 to 23 months: study protocol of NutriVax-Measles, a superiority pragmatic parallel cluster-randomized controlled trial in Yobe State, Northern Nigeria. Trials. 2025 Nov 19;26(1):525. doi: 10.1186/s13063-025-09243-5.
PubMed 41257898
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NutriVax-Measles: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months, a Pragmatic Parallel Cluster-randomized Controlled Trial in Yobe State, Northern Nigeria
- ClinicalTrials.gov ID
- NCT06387511
- Acronym / sponsor ID
- NutriVax-Measles
- Conditions
- Immunization Coverage, Vaccination, Nutrition
- Keywords
- Vaccination coverage, Incentives, Small quantity of Lipid Based Nutrients (SQ-LNS), Measles, Cost-effectiveness, Acceptability, Child, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,814 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Yobe State Primary Health Care Board, Nigeria, Eleanor Crook Foundation, ECF, Gavi, The Vaccine Alliance
- Study start
- 7 May 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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, named the standard EPI arm;
- The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm.
Detailed description
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
- To estimate the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in children aged 6-23 months, after 12 months of program implementation, in terms of 1) all other infant vaccines' uptake, 2) timeliness of age-eligible vaccinations; 3) anthropometric status, 4) uptake of paediatric curative and preventive health consultations and activities.
- To assess the barriers and facilitators to SQ-LNS mass supplementation implemented as part of a routine immunization program in health facilities, from the perspectives of parents/legal guardian of children aged 6-23 months, health care providers and community health workers.
- To assess the cost-efficiency of a SQ-LNS mass supplementation program compared to routine immunization program in terms of cost per child supplemented and vaccinated.
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 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, named the standard EPI arm.
- The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two arms superiority opened pragmatic parallel cluster-randomized controlled trial with baseline measure
| Arm | Type | Receives |
|---|---|---|
| Standard Expanded program on immunization | Active comparator | Behavioral: Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practicesThe 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. |
| NutriVax | Experimental | Dietary Supplement: Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax, Behavioral: Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practicesThe 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. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax1. 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. | Dietary supplement | NutriVax |
| Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices1. 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. | Behavioural | NutriVax, Standard Expanded program on immunization |
Primary outcome
Measles vaccine coverage in children aged 12-23 months
Time frame: Measured after one year after of intervention implementation.
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.
Measles vaccine coverage in children 6-12 months at inclusion
Time frame: Measured after one year after of intervention implementation.
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.
8 secondary outcomes
Measles vaccine coverage: at least one dose
Time frame: Measured after one year after of intervention implementation.
Measles vaccine coverage : two doses
Time frame: Measured after one year after of intervention implementation.
Timeliness of measles 1 vaccination
Time frame: Measured after one year after of intervention implementation.
Other infant vaccines coverage
Time frame: Measured after one year after of intervention implementation.
Zero-dose
Time frame: Measured after one year after of intervention implementation.
Fully immunization
Time frame: Measured after one year after of intervention implementation.
Acceptability
Time frame: Measured after 2 months and one year after of intervention implementation.
Cost-efficiency
Time frame: Measured after one year after of intervention implementation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 42827131Cazes C, Goni BW, Gabillard D, Owolabi O, Yapi B, Nabunje J, Atanga I, Akinyi AM, Danho S, Balestre E, Badje A, Idriss F, Kasim M, Audu Bukarti MM, Emeka CU, Chouinard M, Mushenvula JP, Bahonan S, Plazy M, Abdoulaye O, Chiroma U, Adam HM, Montfort C, Muhammad NS, Becquet R, Phelan KPQ. Small quantity lipid-based nutritional supplementation and measles vaccination coverage in children aged 6-23 months: a pragmatic cluster-randomized trial. Nat Med. 2026 Oct 2. doi: 10.1038/s41591-026-04675-1. Online ahead of print.
- Derived from this study: PubMed 41257898Cazes C, Goni BW, Muhammad NS, Gabillard D, Balonda PK, Feuzeu L, Atanga I, Yapi B, Habiyambere GG, Danho S, Balestre E, Adams KP, Plazy M, Phelan KPQ, Becquet R. Increasing measles vaccination coverage through supplementation with an SQ-LNS incentive in children aged 6 to 23 months: study protocol of NutriVax-Measles, a superiority pragmatic parallel cluster-randomized controlled trial in Yobe State, Northern Nigeria. Trials. 2025 Nov 19;26(1):525. doi: 10.1186/s13063-025-09243-5.
- Resource: A Review \& Proposed Learning Agenda on Immunization Nutrition IntegrationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Possible data sharing agreement, possible one year after publication of the main results.
Related trials for Immunization Coverage
Enrolling by invitation
Randomized Controlled Trial Of Text Messages To Increase Pneumococcal Vaccination In Adults In Chile.
Pneumococcal Infections, Immunization Programs
Recruiting
OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS
Coverage of Vitamin A Supplementation, Coverage of Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud Becquet, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax and Sensitization on vaccination and on Infant and Young Child Feeding (IYCF) practices in people with Immunization Coverage and Vaccination, run by Alliance for International Medical Action at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measles vaccine coverage in children aged 12-23 months (time frame: Measured after one year after of intervention implementation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06387511, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.