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

Author:

Assefa Dawit Getachew12ORCID,Tesefaye Tizalegn32,Bekele Etaferaw12,Geberemickeal Genet12,Mebratu Andualem42,Ejigu Aschalew Gossaye12,Nigatu Tariku5,Zeleke Eden Dagnachew6

Affiliation:

1. Department of Nursing, College of Health Science and Medicine , P.O. Box 419, , Dilla , Ethiopia

2. Dilla University , P.O. Box 419, , Dilla , Ethiopia

3. Department of Public Health, College of Health Science and Medicine , P.O. Box 419, , Dilla , Ethiopia

4. Department of Midwifery, College of Health Science and Medicine , P.O. Box 419, , Dilla , Ethiopia

5. Digital Health Activity, John Snow, Inc. , Boston, MA , USA

6. Ohio State Global One Health Initiative , Addis Ababa , Ethiopia

Abstract

Abstract Background Participant-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. Methods An 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. Results Among 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. Conclusions In 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.

Funder

Dilla University

Publisher

Oxford University Press (OUP)

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