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Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme.

Angelo MG, David MP, Zima J, Baril L, Dubin G, Arellano F, Struyf F - Pharmacoepidemiol Drug Saf (2014)

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.

View Article: PubMed Central - PubMed

Affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.

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Related in: MedlinePlus

Day to onset of 122 potential immune-mediated diseases by MedDRA System Organ Class with onset within 1 year or after any dose of HPV-16/18 vaccine (all study groups (HPV group N = 27 353, Coad group N = 2166, Controls N = 20 504 doses)
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fig03: Day to onset of 122 potential immune-mediated diseases by MedDRA System Organ Class with onset within 1 year or after any dose of HPV-16/18 vaccine (all study groups (HPV group N = 27 353, Coad group N = 2166, Controls N = 20 504 doses)

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).


Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme.

Angelo MG, David MP, Zima J, Baril L, Dubin G, Arellano F, Struyf F - Pharmacoepidemiol Drug Saf (2014)

Day to onset of 122 potential immune-mediated diseases by MedDRA System Organ Class with onset within 1 year or after any dose of HPV-16/18 vaccine (all study groups (HPV group N = 27 353, Coad group N = 2166, Controls N = 20 504 doses)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4230467&req=5

fig03: Day to onset of 122 potential immune-mediated diseases by MedDRA System Organ Class with onset within 1 year or after any dose of HPV-16/18 vaccine (all study groups (HPV group N = 27 353, Coad group N = 2166, Controls N = 20 504 doses)
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).

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.

View Article: PubMed Central - PubMed

Affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.

Show MeSH
Related in: MedlinePlus