Vaccine Adverse Events In Kenya (VAIEK) is a population-based, post-introduction vaccine safety surveillance study of PCV10 in Kenya that will help inform World Health Organization (WHO) vaccine policy.
Synflorix (PCV10) is a 10-valent vaccine against pneumonia presented as a 2-dose vial without a preservative. The vaccine was introduced in the routine immunisation schedule in Kenya in February 2011. This is the first time a preservative-free multi-dose vaccine is being used in a developing country. The VAIEK study will provide data on the use of preservative-free vaccines in developing countries such as Kenya.
The study is being conducted at four sites; Kilifi Health and Demographic Surveillance System (Kilifi HDSS), the KEMRI/CDC Research and Public Health Collaboration International Emerging Infections Program (IEIP) population-based disease surveillance sites in Kibera and Rarieda District, and the KEMRI/CDC HDSS Site in Siaya District. The combined annual birth cohort of the 4 sites is approximately 18,500.
The researchers are investigating adverse events following immunisation (AEFI) associated with PCV10. They utilize data from Health and Demographic Surveillance Systems (HDSS). HDSS are population-based and routinely collect records of births, deaths, vaccination and hospitalizations. In addition, the researchers conduct clinic- and household-based surveillance to investigate suspected injection-site abscesses. Shock and all-cause mortality are investigated through hospital-based and demographic surveillance.
The study team sends a report to WHO and other stakeholders every 6 months. Interim study results are described in the May 2012 WHO statement on immunisation standards and show that there was no detectable increase in AEFIs associated with the use of two-dose preservative free PCV10; however, additional data collection is ongoing and conclusions are pending analyses of the entire study results.
The study is a collaboration between the Division of Vaccines and Immunizations (DVI) in Kenya, KEMRI-Wellcome Trust Research Programme and the KEMRI/CDC Research and Public Health, and is funded by GSK Biologicals.