Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

Summary

Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally. The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.

Timeline

Start

2007-10-04

Primary completion

2014-12-17

Completion

2014-12-17

Publications

• Background Lehtinen M, Eriksson T, Apter D, Hokkanen M, Natunen K, Paavonen J, Pukkala E, Angelo MG, Zima J, David MP, Datta S, Bi D, Struyf F, Dubin G. Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years: Interim analysis of a large community-randomized controlled trial. Hum Vaccin Immunother. 2016 Dec;12(12):3177-3185. doi: 10.1080/21645515.2016.1183847.
• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
• Adhikari I, Eriksson T, Harjula K, Hokkanen M, Apter D, Nieminen P, Luostarinen T, Lehtinen M. Association of Chlamydia trachomatis infection with cervical atypia in adolescent women with short-term or long-term use of oral contraceptives: a longitudinal study in HPV vaccinated women. BMJ Open. 2022 Jun 1;12(6):e056824. doi: 10.1136/bmjopen-2021-056824.
• Gray P, Kann H, Pimenoff VN, Eriksson T, Luostarinen T, Vanska S, Surcel HM, Faust H, Dillner J, Lehtinen M. Human papillomavirus seroprevalence in pregnant women following gender-neutral and girls-only vaccination programs in Finland: A cross-sectional cohort analysis following a cluster randomized trial. PLoS Med. 2021 Jun 7;18(6):e1003588. doi: 10.1371/journal.pmed.1003588. eCollection 2021 Jun.
• Kalliala I, Eriksson T, Aro K, Hokkanen M, Lehtinen M, Gissler M, Nieminen P. Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial. Prev Med. 2021 May;146:106473. doi: 10.1016/j.ypmed.2021.106473. Epub 2021 Feb 24.
• Gray P, Kann H, Pimenoff VN, Adhikari I, Eriksson T, Surcel HM, Vanska S, Dillner J, Faust H, Lehtinen M. Long-term follow-up of human papillomavirus type replacement among young pregnant Finnish females before and after a community-randomised HPV vaccination trial with moderate coverage. Int J Cancer. 2020 Dec 15;147(12):3511-3522. doi: 10.1002/ijc.33169. Epub 2020 Jul 7.
• Vanska S, Luostarinen T, Baussano I, Apter D, Eriksson T, Natunen K, Nieminen P, Paavonen J, Pimenoff VN, Pukkala E, Soderlund-Strand A, Dubin G, Garnett G, Dillner J, Lehtinen M. Vaccination With Moderate Coverage Eradicates Oncogenic Human Papillomaviruses If a Gender-Neutral Strategy Is Applied. J Infect Dis. 2020 Aug 17;222(6):948-956. doi: 10.1093/infdis/jiaa099.
• Bi D, Apter D, Eriksson T, Hokkanen M, Zima J, Damaso S, Soila M, Dubin G, Lehtinen M, Struyf F. Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12-15 years: end-of-study results from a community-randomized study up to 6.5 years. Hum Vaccin Immunother. 2020 Jun 2;16(6):1392-1403. doi: 10.1080/21645515.2019.1692557. Epub 2019 Dec 12.
• Lehtinen M, Apter D, Eriksson T, Harjula K, Hokkanen M, Lehtinen T, Natunen K, Damaso S, Soila M, Bi D, Struyf F. Effectiveness of the AS04-adjuvanted HPV-16/18 vaccine in reducing oropharyngeal HPV infections in young females-Results from a community-randomized trial. Int J Cancer. 2020 Jul 1;147(1):170-174. doi: 10.1002/ijc.32791. Epub 2019 Dec 14.
• Lehtinen M, Luostarinen T, Vanska S, Soderlund-Strand A, Eriksson T, Natunen K, Apter D, Baussano I, Harjula K, Hokkanen M, Kuortti M, Palmroth J, Petaja T, Pukkala E, Rekonen S, Siitari-Mattila M, Surcel HM, Tuomivaara L, Paavonen J, Nieminen P, Dillner J, Dubin G, Garnett G. Gender-neutral vaccination provides improved control of human papillomavirus types 18/31/33/35 through herd immunity: Results of a community randomized trial (III). Int J Cancer. 2018 Nov 1;143(9):2299-2310. doi: 10.1002/ijc.31618. Epub 2018 Aug 10.
• Lehtinen M, Soderlund-Strand A, Vanska S, Luostarinen T, Eriksson T, Natunen K, Apter D, Baussano I, Harjula K, Hokkanen M, Kuortti M, Palmroth J, Petaja T, Pukkala E, Rekonen S, Siitari-Mattila M, Surcel HM, Tuomivaara L, Paavonen J, Dillner J, Dubin G, Garnett G. Impact of gender-neutral or girls-only vaccination against human papillomavirus-Results of a community-randomized clinical trial (I). Int J Cancer. 2018 Mar 1;142(5):949-958. doi: 10.1002/ijc.31119. Epub 2017 Nov 9.
• Lehtinen M, Apter D, Baussano I, Eriksson T, Natunen K, Paavonen J, Vanska S, Bi D, David MP, Datta S, Struyf F, Jenkins D, Pukkala E, Garnett G, Dubin G. Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial. Vaccine. 2015 Mar 3;33(10):1284-90. doi: 10.1016/j.vaccine.2014.12.019. Epub 2015 Jan 12.

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Indications