Implementation Research Zero-dose and Under-immunized Children

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

0 months - 23 months

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

25730 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Background:

This protocol describes both a broader development initiative to address the needs of "zero-dose" (ZD) and under-vaccinated children, and embedded research. The embedded research includes primary data collection through interview and group discussions, and formal implementation research activities. All are funded by Gavi, the vaccine Alliance to generate timely information products for use in tailoring immunization strategies, and in tracking progress in reducing the numbers of ZD and under-vaccinated children.

Every year, nearly 10 million of the 72.5 million children that Gavi aims to reach in low-income countries do not receive a single dose of vaccine. Thus, these children are left susceptible to some of the world's deadliest diseases. The zero-dose (missing first dose of pentavalent vaccine) children account for nearly half of all vaccine-preventable deaths in Bangladesh. Approximately, 45% of the 9.7 million zero-dose (ZD) children reside in urban/peri-urban, remote rural or conflict settings of the country. Notably, about 16-20% of Bangladeshi population remain continuously unvaccinated or under-vaccinated which leaves critical gaps in protection and renders vulnerability to outbreaks.

Gavi and the Global Immunization Agenda 2030 have greatly intensified their emphasis on equity, intending to reach ZD, under-immunized (missing third dose of pentavalent vaccine) children and their communities. Gavi's new five-year strategy 5.0 to improve equity in vaccination coverage hinges on five key intervention areas within the Identify, Reach, Monitor, Measure, and Advocate (IRMMA) framework. To support this, Gavi is setting up "Gavi zero-dose country learning hubs" in order to identify and select a consortium of partners for implementing the learning hubs in Bangladesh, Mali, Nigeria and Uganda. The functioning of a country learning hub in each study country will ensure increased and timely availability of evidence to meet needs prioritized by country level stakeholders and that are aligned with Gavi learning priorities. Therefore, the ZD country learning hub in Bangladesh will conduct implementation research aligning Gavi's IRMMA framework for generating evidence-based interventions for reducing ZD and UI children. This will be accomplished by working in conjunction with the Government, local academic institutions and civil society organizations (CSOs) of the country.

Objectives:

The objectives of the research are to:

1. Understand the effective methods for identifying ZD children and missed communities
2. Identify the key barriers and enabling factors at different levels (policy down to community, and including supply, demand, and gender-related barriers) to identify ZD children
3. Develop and test appropriate approaches to reach ZD children and missed communities and to bring them into the health system in order to achieve full immunization
4. Identify the key barriers and enabling factors at each level (down to community) to reach ZD children and to bring them into the health system through full immunization

Methods:

This quasi-experimental pre-post design study will be conducted in six areas selected via rapid assessment that was conducted by Bangladesh country learning hub team. Each of the selected area will have a comparison area. The duration of the IR will be 18 months starting from September 2023. We will conduct the implementation research to test a set of interventions targeted to six types of areas already known to have higher levels of ZD. Mixed methods approach including baseline and endline household surveys and qualitative methods will be used for evaluation of effectiveness of the interventions. The baseline and endline survey data in the intervention and comparison areas will be analysed for comparison and estimation of difference-in-difference in ZD level. Multivariate analyses will be carried out to estimate the net effect of the intervention on zero-dose level, controlling for all confounders.

Outcome measures/variables:

The primary outcomes are the change(s) in prevalence of "ZD and under-immunized" children from baseline to endline periods.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Children aged 0-23 months
• Living in the selected areas for at least 3 months

Exclusion Criteria:

• Children aged more than 23 months
• Living in the selected areas for less than 3 months

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Study start

Sep 1, 2023 Actual

Primary completion

Sep 30, 2023 Actual

Study completion

Aug 31, 2024 Actual

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.