Evidence map›Paper›PMID 38828522›Full record

Trial reportInternational health2025

Active surveillance of immunization adverse effects: a multicentre, open-label, three-arm randomized uncontrolled trial in Ethiopia.

Dawit Getachew Assefa, Tizalegn Tesefaye, Etaferaw Bekele, Genet Geberemickeal, Andualem Mebratu, Aschalew Gossaye Ejigu, Tariku Nigatu, Eden Dagnachew Zeleke

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05803538 (Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05803538 naunknown statusnot on this map

Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial

TypeinterventionalSponsorDilla UniversityRan2023 to 2024Enrolled391ConditionsMeaslesArmsSMS, telephone interview or diary card
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Dawit Getachew AssefaDepartment of Nursing, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.ORCID 0000-0002-9951-5762
Tizalegn TesefayeDepartment of Public Health, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.
Etaferaw BekeleDepartment of Nursing, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.
Genet GeberemickealDepartment of Nursing, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.
Andualem MebratuDepartment of Midwifery, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.
Aschalew Gossaye EjiguDepartment of Nursing, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.
Tariku NigatuDigital Health Activity, John Snow, Inc., Boston, MA, USA.
Eden Dagnachew ZelekeOhio State Global One Health Initiative, Addis Ababa, Ethiopia.

Funding

Dilla University
6 · The paper itself

Abstract

backgroundParticipant-centred active adverse event following immunization (AEFI) surveillance can offer real-time vaccine safety data and help in signal detection. This study aimed to evaluate the effectiveness of participant-centred active adverse events (AEs) surveillance following measles immunization in Gedeo Zone health facilities in Ethiopia.

methodsAn open-label, multicentred, three-arm randomized uncontrolled trial was conducted from 1 June to 21 October 2023. After assessing enrolment eligibility, the study participants were randomized into three groups (short message service [SMS], telephone interview, and diary card). They were expected to report AEs in children 1 week after receiving immunization. Binary and multivariable logistic regression and χ2 tests were used to analyse the data.

resultsAmong the 396 participants randomized into the three groups, 80.8% (320 participants) reported back about their children's AE status. Participants in the telephone interview group exhibited a substantially superior response rate (93.2% of 132 participants; p<0.00001) compared with the SMS (71.2%) and diary card (78%) groups. The likelihood of reporting the status of AEs experienced by children was lower by 77% (adjusted odds ratio 0.23 [95% confidence interval 0.1 to 0.52], p-value <0.00001) in the diary card group compared with the telephone interview group.

conclusionsIn this study, a telephone interview was found to be the best method for AEFI reporting. Participant-centred active AE surveillance could potentially permit more rapid identification of emerging safety signals. Trial registration:  https://clinicaltrials.gov/ct2/show/NCT05803538.

Indexed as

Adverse Drug Reaction Reporting SystemsImmunizationMeasles VaccineChildChild, PreschoolEthiopiaFemaleHumansInfantMaleText MessagingMeasles Vaccineactive participant-centred reportingadverse event reportingimmunizationpharmacovigilancesurveillancevaccine

Identifiers

PMID38828522
PMCPMC11925019

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.