MeaslesNCT05803538
Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial
A study testing SMS, telephone interview or diary card in people with Measles, run by Dilla University at 1 site in Ethiopia.
Trial summary
Introduction Participant centered active adverse event following immunization (AEFI) surveillance can offer real time vaccine safety data and help in signal detection. Evidence showed that it is still difficult to get AEFI from passive reporting in Ethiopia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Measles
- What is being tested?
- SMS, telephone interview or diary card
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 1 siteEthiopia
- Study dates
- 15 May 2023to 30 Jan 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents, care givers/guardians, whose child receive vaccine.
- ≥18 years of age.
- Willing to adhere to study procedures, which will include a randomization.
- Willing to participate
Who cannot join
- Unable to give informed consent because of cognitive impairment.
- Those who are both illiterate and don't have mobile phone.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Dilla University
Awasa, Snnpr, 419
Dawit G Assefa, MSc, +251912820413, dawitgetachewa@gmail.com
dawitgetachewa@gmail.com
About this study
Introduction Participant centered active adverse event following immunization (AEFI) surveillance can offer real time vaccine safety data and help in signal detection. Evidence showed that it is still difficult to get AEFI from passive reporting in Ethiopia. Vast novel method of enhanced AEFI surveillance has been practiced globally. However, those methods had serious limitations including the requirement of high resource and expertise. Hence, there is a need to find the most flexible low cost and integrated AEFI surveillance system. To the best of our knowledge, there has no published research in Ethiopia which compare Participant diary, SMS, and telephone interview for the purpose of active AEFI surveillance.
Objective: To assess participant centered active adverse event surveillance following measles immunization at Gedeo Zone health facilities, Ethiopia.
Method: An open randomized trial will be employed from October 1, 2022- December 1, 2023, at Gedio Zone health facilities. All parents, care givers/guardians whose child receive vaccine during the study period in the study site will be included in the study. A total of 391participants will be randomized to SMS, telephone interview or diary card group using random number generator on Excel. Every participant will be contacted on day seven to request them whether they experience any AEFI. Differences in proportions will compared using chi-square tests. A 0.05 level of significance will be used for all analyses. Independent sample t-tests will be used to compare the mean time (in days) required to collect complete AEFI data by SMS, telephone interview and diary card. Multinominal logistic regression analyses will be used assess the factors associated with effective use of tailored SMS, telephone interview and diary card for the AEFI active surveillance. To further investigate the association between the vaccine and the adverse events and factors associated with vaccine binary and multi variable logistic regression will be used.
- Conditions
- Measles
- Being tested
- SMS, telephone interview or diary card
- Keywords
- Participant Centered Active Surveillance, Adverse Event, Measles Immunization
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS, telephone interview or diary cardDevice
SMS, telephone interview or diary card
| Study group | Role | What they receive |
|---|---|---|
| SMS | Experimental | Not described Receives: Device: SMS, telephone interview or diary card |
| Telephone interview | Experimental | Not described Receives: Device: SMS, telephone interview or diary card |
| Diary card | Experimental | Not described Receives: Device: SMS, telephone interview or diary card |
| Usual Care | Active comparator | Not described Receives: Device: SMS, telephone interview or diary card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
To compare response rate of tailored SMS, telephone interview and diary card for the AEFI active surveillance
Measured: 7 days
Secondary outcomes (1)
AEFI's reported from each group and feasibility of participant centered AEFI active surveillance
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 May 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 391 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawit Getachew Getachew, Dilla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803538
- Sponsor's protocol ID
- ETDU005
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Assefa DG, Tesefaye T, Bekele E, Geberemickeal G, Mebratu A, Ejigu AG, Nigatu T, Zeleke ED. Active surveillance of immunization adverse effects: a multicentre, open-label, three-arm randomized uncontrolled trial in Ethiopia. Int Health. 2025 Mar 4;17(2):195-204. doi: 10.1093/inthealth/ihae040.
PubMed 38828522
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05803538
- Acronym / sponsor ID
- ETDU005
- Conditions
- Measles
- Keywords
- Participant Centered Active Surveillance, Adverse Event, Measles Immunization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 391 participants (estimated)
- Lead sponsor
- Dilla UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 7 Apr 2023 (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.
Introduction Participant centered active adverse event following immunization (AEFI) surveillance can offer real time vaccine safety data and help in signal detection. Evidence showed that it is still difficult to get AEFI from passive reporting in Ethiopia. Vast novel method of enhanced AEFI surveillance has been practiced globally. However, those methods had serious limitations including the requirement of high resource and expertise. Hence, there is a need to find the most flexible low cost and integrated AEFI surveillance system. To the best of our knowledge, there has no published research in Ethiopia which compare Participant diary, SMS, and telephone interview for the purpose of active AEFI surveillance.
Objective: To assess participant centered active adverse event surveillance following measles immunization at Gedeo Zone health facilities, Ethiopia.
Method: An open randomized trial will be employed from October 1, 2022- December 1, 2023, at Gedio Zone health facilities. All parents, care givers/guardians whose child receive vaccine during the study period in the study site will be included in the study. A total of 391participants will be randomized to SMS, telephone interview or diary card group using random number generator on Excel. Every participant will be contacted on day seven to request them whether they experience any AEFI. Differences in proportions will compared using chi-square tests. A 0.05 level of significance will be used for all analyses. Independent sample t-tests will be used to compare the mean time (in days) required to collect complete AEFI data by SMS, telephone interview and diary card. Multinominal logistic regression analyses will be used assess the factors associated with effective use of tailored SMS, telephone interview and diary card for the AEFI active surveillance. To further investigate the association between the vaccine and the adverse events and factors associated with vaccine binary and multi variable logistic regression will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SMS | Experimental | Device: SMS, telephone interview or diary card |
| Telephone interview | Experimental | Device: SMS, telephone interview or diary card |
| Diary card | Experimental | Device: SMS, telephone interview or diary card |
| Usual Care | Active comparator | Device: SMS, telephone interview or diary card |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parents, care givers/guardians, whose child receive vaccine.
- ≥18 years of age.
- Willing to adhere to study procedures, which will include a randomization.
- Willing to participate
Key exclusion criteria (2 listed)
- Unable to give informed consent because of cognitive impairment.
- Those who are both illiterate and don't have mobile phone.
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 |
|---|---|---|
| SMS, telephone interview or diary cardSMS, telephone interview or diary card | Device | Diary card, SMS, Telephone interview, Usual Care |
Primary outcome
Response rate
Time frame: 7 days
To compare response rate of tailored SMS, telephone interview and diary card for the AEFI active surveillance
1 secondary outcome
AEFI's reported from each group and feasibility of participant centered AEFI active surveillance
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 38828522Assefa DG, Tesefaye T, Bekele E, Geberemickeal G, Mebratu A, Ejigu AG, Nigatu T, Zeleke ED. Active surveillance of immunization adverse effects: a multicentre, open-label, three-arm randomized uncontrolled trial in Ethiopia. Int Health. 2025 Mar 4;17(2):195-204. doi: 10.1093/inthealth/ihae040.
- Individual participant dataSharing planned: Undecided
Related trials for Measles
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Heart Transplant Infection Prevention
Active, not recruitingPhase 1/2
MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma
Not yet recruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Measles, Mumps
RecruitingPhase 1
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS, telephone interview or diary card in people with Measles, run by Dilla University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. 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 Ethiopia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 7 days). 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 NCT05803538, which also lists 1 linked publication.
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 7 Apr 2023.