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This entry refers to the active control vaccine regimen utilized by the Butantan Institute in the Xo_Gripe clinical trial (2009). The regimen was designed to maintain the double-blind nature of the study evaluating a trivalent inactivated influenza vaccine in schoolchildren. Depending on the child's age and the required number of influenza doses (one or two), the control consisted of either a single dose of a meningococcal C conjugate vaccine (manufactured by Chiron Corporation) or a two-dose sequence involving the meningococcal C vaccine followed by a varicella vaccine (manufactured by Green Cross Corp) 30 days later. This approach provided the control group with protection against unrelated pathogens while mimicking the administration schedule of the experimental influenza vaccine.
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