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2016 ; 26
(ä): 16
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Literature review of vaccine-related adverse events reported from HPV vaccination
in randomized controlled trials
#MMPMID27895921
Macki M
; Dabaja AA
Basic Clin Androl
2016[]; 26
(ä): 16
PMID27895921
show ga
BACKGROUND: The human papilloma virus (HPV) infections were addressed with two
FDA-approved HPV vaccines: quadrivalent and bivalent vaccine. The objective of
this manuscript is to determine the safety of the HPV vaccine. RESULTS: A search
of PubMed articles for "human papillomavirus vaccine" was used to identify
all-type HPV clinical studies prior to October 2014. A refined search of clinical
trials, multicenter studies, and randomized studies were screened for only
randomized controlled trials comparing HPV vaccine to controls (saline placebo or
aluminum derivatives). Studies were limited to the two FDA-approved vaccines.
Following PRISMA guidelines, the literature review rendered 13 publications that
met inclusion/ exclusion criteria. Gender was limited to females in 10 studies
and males in 1 study. Two studies included both males and females. Of the 11,189
individuals in 7 publications reporting cumulative, all-type adverse events (AE),
the AE incidence of 76.52 % (n?=?4544) in the vaccinated group was statistically
significantly higher than 67.57 % (n?=?3548) in the control group (p?0.001).
The most common AE were injection-site reactions. On the other hand, systemic
symptoms did not statistically significantly differ between the vaccination
cohort (35.28 %, n?=?3351) and the control cohort (36.14 %, n?=?3198)
(p?=?0.223). The pregnancy/ perinatal outcomes rendered no statistically
significant difference between the vaccine group and control group. CONCLUSION:
Because the statistically significantly higher incidence of AE in the HPV vaccine
group was primarily limited to injection-site reactions, the vaccinations are
safe preventative measures in both males and females.