Estruch-de la Guardia R, Barrera-Suarez BA, Mirabal-Sosa M, Armesto-del Río M, García-Sánchez HM, Cedré-Marrero B

Language: Spanish
References: 19
Page: 17-23
PDF size: 114.68 Kb.

ABSTRACT

A randomized, controlled and at double blind study was conducted in 352 young Cuban adults between 18 and 35 years old, with the objective of evaluating the safety, reactogenicity and immunogenicity of a new polysaccharide vaccine of Neisseria meningitidis serogroups A, C and W₁₃₅, manufactured by the Finlay Institute of Cuba, with regard to its similar commercial Mencevax^® ACW of Glaxo SmithKline. Samples of serum were taken before and 28 days after vaccination. The reactogenicity of both vaccines was similar. The symptoms and signs, as locals as generals were slight and they appeared mainly during the fi rst 48 h after vaccination. No subject showed serious adverse events during the 28 days of the surveillance period. The vaccine in study proved to be safe and little reactogenic; Its seroconversion percentages at the 28 days after vaccination were of: 92.19 % for the serogroup A, 88.89 % for C and 90.06 % for W₁₃₅. Differences regarding the seroconversion were not detected. The seroprotection reached with the vaccine in study was 98.44 %, 91.81 % and 95.32 % for the serogroups A, C and W₁₃₅ respectively and it was not inferior regarding the control vaccine for the three studied serogroups.

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