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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

Percentage (95%CIs) of all women reporting all unsolicited adverse symptoms, medically significant conditions, potential immune-mediated diseases and serious adverse events after vaccination (Total vaccinated cohort): 30-day and entire study follow-up periods
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fig02: Percentage (95%CIs) of all women reporting all unsolicited adverse symptoms, medically significant conditions, potential immune-mediated diseases and serious adverse events after vaccination (Total vaccinated cohort): 30-day and entire study follow-up periods

Mentions: Symptoms were reported within 30 days after each dose by 30.8% (95%CI 30.2–31.3) of subjects in the HPV group, 29.7% (29.1–30.3) of controls and 48.1% (45.9–50.2) in the Coad group (Figure 2). The most frequently reported Preferred Terms in each group were upper respiratory tract infection, nasopharyngitis and headache.


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)

Percentage (95%CIs) of all women reporting all unsolicited adverse symptoms, medically significant conditions, potential immune-mediated diseases and serious adverse events after vaccination (Total vaccinated cohort): 30-day and entire study follow-up periods
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig02: Percentage (95%CIs) of all women reporting all unsolicited adverse symptoms, medically significant conditions, potential immune-mediated diseases and serious adverse events after vaccination (Total vaccinated cohort): 30-day and entire study follow-up periods
Mentions: Symptoms were reported within 30 days after each dose by 30.8% (95%CI 30.2–31.3) of subjects in the HPV group, 29.7% (29.1–30.3) of controls and 48.1% (45.9–50.2) in the Coad group (Figure 2). The most frequently reported Preferred Terms in each group were upper respiratory tract infection, nasopharyngitis and headache.

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