HEXAVALENT VACCINE IN EUROPE: SAFETY DATA FROM THE
RANDOMIZED CLINICAL TRIALS
NOÉMI-BEÁTRIX BULIK 1*, CAMELIA BUCȘA 2, ANDREEA FARCAȘ 2, OVIDIU ONIGA 1
1Pharmaceutical Chemistry Department, “Iuliu Hațieganu” University of Medicine and Pharmacy, 41 Victor Babeș Street,
400012, Cluj-Napoca, Romania
2Drug Information Research Centre, “Iuliu Hațieganu” University of Medicine and Pharmacy, 6 Pasteur Street, 400349,
Cluj-Napoca, Romania
*corresponding author: bulik.noemi@umfcluj.ro
DownloadDownload Full Article

Abstract:
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.






Top