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Safety of HPV vaccination: A FIGO statement
Author(s) -
Lynette Denny
Publication year - 2013
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2013.09.009
Subject(s) - medicine , adverse effect , vaccination , population , clinical trial , placebo , randomized controlled trial , pediatrics , environmental health , immunology , alternative medicine , pathology
• Safety Findings of clinical trials of the quadrivalent vaccine: o Pooled analyses of trials involving more than 20 000 females aged 9 – 26 years and 1350 males aged 9 – 16 years from Europe, North and South America, showed that injection site reactions such as pain, erythema and swelling were more common in vaccine recipients than in those who received adjuvant or placebo vaccinations. In almost all cases, symptoms were self-limiting and resolved within 48 hours o There was no difference in common adverse experiences such as headache, fever and nausea o There was also no difference in the frequency of SAEs overall or by organ system over a median follow up of just under 4 years o Deaths occurred in 0.1% in both the vaccine and placebo groups, with no deaths deemed vaccine related o The overall proportion of participants reporting new onset autoimmune conditions was not different in each group (2.4% in both) over the 4 year follow up period