Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme.
Bottom Line: Coadministration did not change the overall safety profile.No new safety signals were identified.The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and adult women.
Affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.Show MeSH
Related in: MedlinePlus
Mentions: The percentage of subjects reporting pIMDs within 30 days of any vaccine dose, and within the entire study period, was similar in each group (Figure 2). Within 1 year of any dose, pIMDs were reported with equal frequencies in the three study groups (0.2%). Of five subjects who reported two pIMDs, three reported exacerbations of the disease (Crohn's disease, rheumatoid arthritis, ulcerative colitis). The most frequently reported events within 1 year of any dose were cranial nerve disorders (6/27 353 subjects in the HPV group and 6/20 504 controls), psoriasis (seven and five cases, respectively), Grave's disease (seven and three cases, respectively), autoimmune thyroiditis and vasculitis (four cases of each in the HPV group and controls), rheumatoid arthropathies (five and three cases, respectively) and neuritis (three and five cases, respectively). No clustering of events in terms of the time-to-onset was evident in the year following any dose (Figure 3).