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HEXAVALENT VACCINE IN EUROPE: SAFETY DATA FROM THE RANDOMIZED CLINICAL TRIALS

NOÉMI-BEÁTRIX BULIK ^1*, CAMELIA BUCȘA ², ANDREEA FARCAȘ ², OVIDIU ONIGA ¹

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Any vaccine safety issue affects the public confidence in vaccines. This study summarized the safety data published in randomized clinical trials from Europe on the hexavalent vaccine (diphtheria-tetanus-pertussis toxoid, inactivated poliomyelitis virus, antigens against hepatitis B and Haemophilus influenzae type B polysaccharide) administered alone or together with other paediatric vaccines, published between 2000–2016. The solicited adverse events (AEs), unsolicited AEs (uAEs) and serious AEs (SAEs) were evaluated. We included 15 studies summing up 6,618 children with the age between 2 - 24 months. Grade 3 local reactions ranged between 1.1% - 15.5% for redness, 0.4% - 7.4% for pain and 1.4% - 9.7% for swelling. Irritability and fever were the most frequently reported general symptoms. The incidence of fever ranged between 11.0% - 57.3%, while grade 3 fever (> 39.5ºC) affected up to 15.9% of children. The rate of fever slightly increased when the hexavalent vaccine was co-administered with other paediatric vaccines as compared to the hexavalent vaccine alone (30.8% - 76.7% vs 11.0% - 57.3%). Toddlers experienced fever with a slightly increased incidence as compared to infants (31.1% - 52.1% vs 9.2% - 46.3%). uAEs ranged between 17.7% - 51.1% for hexavalent vaccine administered alone or concomitantly with other paediatric vaccines. No vaccine-related SAEs were reported for the hexavalent vaccine administered alone, while four vaccine-related SAEs (urticaria, febrile seizure, hypotonic-hyporesponsive episode and Kawasaki disease) were reported when this was co-administered with other paediatric vaccines. The reviewed studies from Europe, published between 2000 - 2016, showed that hexavalent vaccine was generally well tolerated as primary and booster vaccination.