Introduction:

The present and future impossibility of having the Cuban DPT-VAX® vaccine, administered as a booster to the child population at 18 months of age, together with the economic and financial difficulties to buy and import a foreign vaccine, impose on the National Immunization Program the challenge of evaluating other alternatives.

Objective:

To evaluate the safety of the Heberpenta-L® vaccine as a booster from 18 months of age.

Methods:

Research on evaluative services and systems. Temporal horizon between November 2018 and July 2019. It designed a quasi-experimental community-based trial in nine health areas that were selected by simple staged random sampling. The universe was composed of 2 466 children. The appearance of adverse events associated with vaccination or immunization (ESAVI) was observed in the first hour, at 24, 48, 72 hours, and seven days, after the administration of the Heberpenta-L® vaccine

Results:

The most frequent ESAVI were: fever 63.2 %, considered very common, followed by local reactions at the injection site such as redness in 14.3 %. 67 % were systemic, common (84 %) and mild (83 %), no serious event was reported 98.3 % (281) had a causal association with the vaccine.

Conclusions:

The results obtained do not differ from those reported for the primary series of this vaccine, which supports the safety profile for its use as a booster dose.

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