uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomized, controlled trial in adolescent girls
Show others and affiliations
2010 (English)In: Journal of Adolescent Health, ISSN 1054-139X, E-ISSN 1879-1972, Vol. 46, no 5, 414-421 p.Article in journal (Refereed) Published
Abstract [en]


Immunization of girls against oncogenic human papillomavirus (HPV) types before sexual debut is important for cervical cancer prevention. This phase III blinded, randomized, controlled trial in adolescent girls assessed safety of the HPV-16/18 AS04-adjuvanted vaccine.


Girls (mean age 12 years) in 12 countries received the HPV-16/18 L1 virus-like particle AS04-adjuvanted vaccine (N = 1,035) or hepatitis A virus vaccine as control (N = 1,032) at 0, 1, and 6 months. The primary objective was to compare the occurrence of serious adverse events (SAEs) between groups. HPV-16 and HPV-18 antibody titers were assessed by enzyme-linked immunosorbent assay post-vaccination.


Up to study month 7, 11 girls in the HPV-16/18 vaccine group reported 14 SAEs and 13 girls in the control group reported 15 SAEs. The difference in SAE incidence between groups was .20% (95% CI, -.78, 1.20). No SAE in the HPV-16/18 vaccine group was considered related to vaccination or led to withdrawal. The incidence of solicited local and general symptoms up to 7 days post-vaccination was moderately higher with the HPV-16/18 vaccine than with control. The incidence of unsolicited symptoms, new onset of chronic diseases, and medically significant conditions was similar between groups. All girls seroconverted for both antigens after three doses of the HPV-16/18 vaccine; geometric mean titers were 19,882.0 and 8,262.0 EU/mL for anti-HPV-16 and -18 antibodies, respectively, in initially seronegative girls.


The HPV-16/18 AS04-adjuvanted vaccine was generally well tolerated and immunogenic when administered to young adolescent females, the primary target of organized vaccination programs.

Place, publisher, year, edition, pages
2010. Vol. 46, no 5, 414-421 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-197824DOI: 10.1016/j.jadohealth.2010.02.006PubMedID: 20413076OAI: oai:DiVA.org:uu-197824DiVA: diva2:614390
Available from: 2013-04-04 Created: 2013-04-04 Last updated: 2013-04-05Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed
By organisation
Centrum för klinisk forskning i Sörmland (CKFD)
In the same journal
Journal of Adolescent Health
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 178 hits
ReferencesLink to record
Permanent link

Direct link