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Title: 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]
Authors: 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
Wasan, S.M
Khan, M.J
Abu-Elyazeed, R
Ivanoff, B
Galindo, C.M
Pang, T 
Donner, A
Von Seidlein, L
Acosta, C.J
Clemens, J.D
Nizami, S.Q
Bhutta, Z.A
Keywords: hepatitis A vaccine
polysaccharide vaccine
bleeding disorder
clinical trial
cluster analysis
controlled clinical trial
controlled study
cost effectiveness analysis
double blind procedure
drug cost
drug fever
feasibility study
infection control
informed consent
major clinical study
mass immunization
medical documentation
population research
preventive health service
randomized controlled trial
risk assessment
typhoid fever
urban area
Issue Date: 2006
Publisher: BMC
Citation: 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, Wasan, S.M, Khan, M.J, Abu-Elyazeed, R, Ivanoff, B, Galindo, C.M, Pang, T, Donner, A, Von Seidlein, L, Acosta, C.J, Clemens, J.D, Nizami, S.Q, Bhutta, Z.A (2006). 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]. Trials 7 : 17. ScholarBank@NUS Repository.
Rights: Attribution 4.0 International
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.
Source Title: Trials
ISSN: 1745-6215
DOI: 10.1186/1745-6215-7-17
Rights: Attribution 4.0 International
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