Virology & Mycology
Open Access
ISSN: 2161-0517
ISSN: 2161-0517
Nivaldo Linares-Perez, Maria E Toledo-Romani, Maria F Casanova, Beatriz Paredes and Ivan Cueva
Valdespino Finlay Vaccine Institute, Cuba
Tropical Medicine Institute â??Pedro Kour?â?, Cuba
University Pediatric Hospital â??Paquito Gonz?¡lez Cuetoâ?, Cuba
Posters & Accepted Abstracts: Virol Mycol
Background and Aims: A new pneumococcal conjugate vaccine is currently undergoing advanced clinical evaluation in Cuba. We present the safety profile of the vaccine candidate (PCV7-TT) administered in real life conditions in children 1-5 years as part of the planned introduction strategy. Methods: The implementation Cuban strategy has been designed with consideration of the need to maximize the effects of vaccination. Cluster non-randomized trial stepped wedge design is currently being implemented through a massive campaign high coverage (â?¥90%) with PCV7-TT. The inclusion criteria or the first stage of the intervention (October-November 2017) were children 1-5 yearsâ?? local resident whose parents signed the informed consent for the vaccination and the follow-up study. The main endpoint defined was the proportion of adverse events attributable to vaccination at 7 and 30 days after the immunization. Results: 4138 children were vaccinated (672 of 12-23 months and 3466 of 3-5 years). 4810 dose were administered. 15 (0.31%) serious adverse events were reported after the immunization (hospitalization required), none causal related with vaccination. 77 vaccinated children report 126 adverse events. The local adverse events (71.5%) dominated: Increase local volume (19.6%), redness (17.6%), induration (12.7%), and pain at the injection site (8.8%). The most common systemic adverse event was fever <39?°C (16.6%). Rate of systemic and local adverse events per dose applied (x 1000) was the 15.1 and 6.4, respectively. Conclusions: The Cuban pneumococcal vaccine candidate is safe. The contribution of the introduction strategy could support the decision-making to introduce the new vaccine in Cuba and shift of paradigm from the individual protection to population effect based on scientific evidences.