MONITORING ADVERSE REACTIONS OF THE CANTGRIP® VACCINE
CRISTINA POP1, ANDREEA MARIA FARCAS1*, DANIEL CORNELIU LEUCUTA2, CAMELIA BUCSA1, DANA FARAIAN3, DAN RAZVAN FLOREA3, DOINA TATULESCU4, MARIUS TRAIAN BOJITA1
1Drug Information Research Center, School of Pharmacy, University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca;
2Medical Informatics and Biostatistics Department, University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj-Napoca;
3Epidemiology Center, Territorial Emergency Hospital, Cluj-Napoca;
4Infectious Disease Clinical Hospital, Cluj-Napoca;
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Post-marketing vaccine safety monitoring is an important component of all
vaccination programs. Early detection and quick response to adverse events following
immunization can lessen their negative impact on health and on immunization programs
themselves. For this reason, the current non-interventional, prospective study developed a
method of further evaluating the safety of the Cantgrip® vaccine for influenza virus
A(H1N1) manufactured and used in Romania. A total of 371 questionnaires were
distributed to the health-care professionals at the moment of the immunization, 309 subjects
returned the questionnaires in two weeks’ time. The most common injection-site reaction
was pain (48.5%). Other local adverse reactions were redness, irritation and induration. The
most common systemic adverse reactions reported were: muscle ache (8.7%), chills (2.9%)
and sweating (1.9%). Most of the reported adverse reactions following immunization were
mild-to-moderate. No life-threatening or adverse events of special interest were reported.
The results of our study showed that, for an initial follow up of the studied group of
subjects, Cantgrip® proved to be a safe vaccine.
