Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: An experience from a cluster-randomized double-blinded vaccine trial [NCT00125047]
Khan, M.I Ochiai, R.L Hamzal, H.B Sahito, S.M Habib, M.A Soofi, S.B Bhutto, N.S Rasool, S Puri, M.K Ali, M
Khan, M.I
Ochiai, R.L
Hamzal, H.B
Sahito, S.M
Habib, M.A
Soofi, S.B
Bhutto, N.S
Rasool, S
Puri, M.K
Ali, M
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Alternative Title
Abstract
Objective: To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. Methods: A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. Results: The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. Conclusion: This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc) will make typhoid fever control become a reality in the near future. © 2006 Khan et al; licensee BioMed Central Ltd.
Keywords
hepatitis A vaccine, polysaccharide vaccine, typherix, abscess, adolescent, article, bleeding disorder, child, clinical trial, cluster analysis, controlled clinical trial, controlled study, cost effectiveness analysis, double blind procedure, drug cost, drug fever, feasibility study, female, human, infection control, informed consent, major clinical study, male, mass immunization, medical documentation, monitoring, pain, Pakistan, pediatrics, petechia, population research, preventive health service, randomized controlled trial, risk assessment, standard, swelling, typhoid fever, urban area, vaccination
Source Title
Trials
Publisher
BMC
Series/Report No.
Collections
Rights
Attribution 4.0 International
Date
2006
DOI
10.1186/1745-6215-7-17
Type
Article