VaccinesTHEIANCT06745635
A Multifaceted Intervention on Reducing Immunization Errors
A study testing Multifaceted intervention in people with Vaccines and Vaccines Adverse Reaction, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
The goal of this trial is to reduce the general error related to vaccines and immunizations (composited on secondary endpoint), after 11 moths of folow-up after cluster randomization and stepped wedge on primary care on brazilian public health. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccines, Vaccines Adverse Reaction, Vaccine Practice
- What is being tested?
- Multifaceted intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jul 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Cluster Inclusion Criteria
- Health units with vaccination rooms administering at least 2,000 doses of vaccines/immunobiologicals per month,
Cluster Exclusion Criteria
- Primary health units that do not provide consistent vaccination services to the population.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo
Henrique Fonseca, +55 (11) 2151-1233, henrique.fonseca@einstein.br
About this study
Official title: A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial
The goal of this trial is to reduce the general error related to vaccines and immunizations (composited on secondary endpoint), after 11 moths of folow-up after cluster randomization and stepped wedge on primary care on brazilian public health.
The main questions it aims to answer are:
- To evaluate the effectiveness of a multifaceted intervention in vaccination rooms in reducing vaccination errors.
- To describe the rate of adverse events following immunization (AEFI) and the associated factors.
Read the detailed description
Researchers will compare two times in a Stepped Wedge design:
- Usual Care :All sites will follow the standard practices for vaccine management and immunization in health units with vaccination rooms during 1 month. All sites will be randomized into 11 steps (corresponding to the number of stages required to complete the 12-month study). At each step, 8 clusters (each containing one immunization service within a primary care facility) will receive the intervention."
- Multifaceted Strategy :*This time will implement a multifaceted quality improvement and process strategy composed of:
- Video-based training on vaccine management.
- Development of an optimized Cold Chain Manual, streamlining guidelines for vaccine handling.
- Technical documents providing comprehensive guidance on the appropriate management of vaccines and their respective immunization schedules.
- Technical documentsaddressing the management of errors identified post-vaccination and offering recommendations for public guidance.
- Conditions
- Vaccines, Vaccines Adverse Reaction, Vaccine Practice
- Being tested
- Usual Care, Multifaceted intervention
- Keywords
- Cluster-randomized controlled trial, Multifaceted intervention, Quality improvement in immunization, Vaccination errors, Vaccination safety, Primary health care, Vaccination room management, Cold chain management, Public health improvement, Health systems implementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Usual care for immunizations.
Multifaceted interventionOther
The multifaceted quality improvement intervention includes: video-based training on vaccine management in SUS, an optimized Cold Chain Manual schema, technical documents on proper vaccine handling and immunization schedules, and checklists for managing post-vaccination errors and corrective procedures. Videos will focus on six key points (right person, vaccine, dose, time, route, and documentation), with each lasting about 2 minutes and accessible on-demand. The Cold Chain schema will cover storage, monitoring, transport, conservation, and handling, with checklists for each category. Standardized technical documents will align with video themes, ensuring protocol adherence. An error identification and management schema will address issues like improper vaccine administration, cold chain violations, and incorrect dosages. This schema will be reviewed by staff and made available in health units.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Other | This arm will continue to follow the routine activities and standard procedures established by the public health system. Receives: Other: Usual Care |
| Multifaceted Intervention Group | Other | This group will implement a multifaceted quality improvement and process strategy composed of:
Video-based training on vaccine management. Development of an optimized Cold Chain Manual, streamlining guidelines for vaccine handling.
Technical documents providing comprehensive guidance on the appropriate management of vaccines and their respective immunization schedules.
Technical documents addressing the management of errors identified post-vaccination and offering recommendations for public guidance Receives: Other: Multifaceted intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of overall errors attributable to vaccination and immunization processes.
The primary composite outcome is defined as the reduction of overall errors attributable to vaccination and immunization processes, including: dilution errors, administration of vaccines outside the recommended age, errors related to inappropriate intervals between doses/vaccines, errors in the use of immunobiologicals, errors related to repeated doses, administration of vaccines not recommended during pregnancy, errors in the storage and handling of vaccines and immunobiologicals, and administration of vaccines via incorrect routes.
Measured: From Randomization to the end of Follow-up (12 months)
Secondary outcomes (1)
incidence of the components of the primary outcome
Rate of the components of the primary outcome.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start3 Jul 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A Stepped-Wedge Cluster Randomized Trial (SW-CRT) is a type of clinical trial in which the intervention is progressively implemented across clusters (groups) over time in a staggered and randomized manner. Initially, all clusters start in the control group, and in successive steps, one or more clusters are randomly selected to receive the intervention. This process continues until all clusters have been exposed to the intervention.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Henrique A Fonseca, ScD, PhD, Study chair, Hospital Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745635
- Sponsor's protocol ID
- THEIA trial
- Acronym
- THEIA
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifaceted Intervention on Reducing Immunization Errors: a Pragmatic, Stepped-wedge, Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06745635
- Acronym / sponsor ID
- THEIA / THEIA trial
- Conditions
- Vaccines, Vaccines Adverse Reaction, Vaccine Practice
- Keywords
- Cluster-randomized controlled trial, Multifaceted intervention, Quality improvement in immunization, Vaccination errors, Vaccination safety, Primary health care, Vaccination room management, Cold chain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 3 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Dec 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.
The goal of this trial is to reduce the general error related to vaccines and immunizations (composited on secondary endpoint), after 11 moths of folow-up after cluster randomization and stepped wedge on primary care on brazilian public health.
The main questions it aims to answer are:
- To evaluate the effectiveness of a multifaceted intervention in vaccination rooms in reducing vaccination errors.
- To describe the rate of adverse events following immunization (AEFI) and the associated factors.
Detailed description
Researchers will compare two times in a Stepped Wedge design:
- Usual Care :All sites will follow the standard practices for vaccine management and immunization in health units with vaccination rooms during 1 month. All sites will be randomized into 11 steps (corresponding to the number of stages required to complete the 12-month study). At each step, 8 clusters (each containing one immunization service within a primary care facility) will receive the intervention."
- Multifaceted Strategy :*This time will implement a multifaceted quality improvement and process strategy composed of:
- Video-based training on vaccine management.
- Development of an optimized Cold Chain Manual, streamlining guidelines for vaccine handling.
- Technical documents providing comprehensive guidance on the appropriate management of vaccines and their respective immunization schedules.
- Technical documentsaddressing the management of errors identified post-vaccination and offering recommendations for public guidance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Stepped-Wedge Cluster Randomized Trial (SW-CRT) is a type of clinical trial in which the intervention is progressively implemented across clusters (groups) over time in a staggered and randomized manner. Initially, all clusters start in the control group, and in successive steps, one or more clusters are randomly selected to receive the intervention. This process continues until all clusters have been exposed to the intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Other | Other: Usual CareThis arm will continue to follow the routine activities and standard procedures established by the public health system. |
| Multifaceted Intervention Group | Other | Other: Multifaceted interventionThis group will implement a multifaceted quality improvement and process strategy composed of: Video-based training on vaccine management. Development of an optimized Cold Chain Manual, streamlining guidelines for vaccine handling. Technical documents providing comprehensive guidance on the appropriate management of vaccines and their respective immunization schedules. Technical documents addressing the management of errors identified post-vaccination and offering recommendations for public guidance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Usual CareUsual care for immunizations. | Other | Usual Care Group |
| Multifaceted interventionThe multifaceted quality improvement intervention includes: video-based training on vaccine management in SUS, an optimized Cold Chain Manual schema, technical documents on proper vaccine handling and immunization schedules, and checklists for managing post-vaccination errors and corrective procedures. Videos will focus on six key points (right person, vaccine, dose, time, route, and documentation), with each lasting about 2 minutes and accessible on-demand. The Cold Chain schema will cover storage, monitoring, transport, conservation, and handling, with checklists for each category. Standardized technical documents will align with video themes, ensuring protocol adherence. An error identification and management schema will address issues like improper vaccine administration, cold chain violations, and incorrect dosages. This schema will be reviewed by staff and made available in health units. | Other | Multifaceted Intervention Group |
Primary outcome
Reduction of overall errors attributable to vaccination and immunization processes.
Time frame: From Randomization to the end of Follow-up (12 months)
The primary composite outcome is defined as the reduction of overall errors attributable to vaccination and immunization processes, including: dilution errors, administration of vaccines outside the recommended age, errors related to inappropriate intervals between doses/vaccines, errors in the use of immunobiologicals, errors related to repeated doses, administration of vaccines not recommended during pregnancy, errors in the storage and handling of vaccines and immunobiologicals, and administration of vaccines via incorrect routes.
1 secondary outcome
incidence of the components of the primary outcome
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Henrique A Fonseca, ScD, PhD study chair
Hospital Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted intervention in people with Vaccines and Vaccines Adverse Reaction, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio C Mattos, MSc (+55 (11) 2151-1233, antonio.mattos@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of overall errors attributable to vaccination and immunization processes. (time frame: From Randomization to the end of Follow-up (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025.