Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects

Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either vaccine alone. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start

2007-02-13

Primary completion

2008-03-17

Completion

2008-07-25

Outcome

Met primary endpoint

paper Coadministered dTpa-IPV and HPV vaccine was noninferior to dTpa-IPV alone in terms of seroprotection against diphtheria (99.2% and 100%), PMID 20113920 ↗

paper Coadministered dTpa-IPV and HPV vaccine was noninferior to HPV vaccine alone in terms of seroconversion rates for HPV-16 PMID 20113920 ↗

Publications

• Background Schwarz T et al. Co-administration of AS04-adjuvanted HPV-16/18 cervical cancer vaccine with DTPA-IPV in 10-18 year old girls: Month 7 results from a randomized trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
• 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.
• Garcia-Sicilia J, Schwarz TF, Carmona A, Peters K, Malkin JE, Tran PM, Behre U, Iturbe EB, Catteau G, Thomas F, Dobbelaere K, Descamps D, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine coadministered with combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine to girls and young women. J Adolesc Health. 2010 Feb;46(2):142-51. doi: 10.1016/j.jadohealth.2009.11.205.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boostrix Polio	Vaccine	—	Intramuscular
Subject	Cervarix	Vaccine	—	Intramuscular

Indications