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A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil® in 9–15-Year-Old Girls

Vesikari, Timo MD, PhD*; Brodszki, Nicholas MD; van Damme, Pierre MD, PhD; Diez-Domingo, Javier MD, PhD§; Icardi, Giancarlo MD; Petersen, Lone Kjeld DMSc; Tran, Clément MSc**; Thomas, Stéphane MSc**; Luxembourg, Alain MD, PhD††; Baudin, Martine MD**

Pediatric Infectious Disease Journal: September 2015 - Volume 34 - Issue 9 - p 992–998
doi: 10.1097/INF.0000000000000773
Vaccine Reports

Background: A 9-valent human papillomavirus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 [as per the licensed quadrivalent HPV (qHPV) vaccine], as well as 5 additional oncogenic HPV types (HPV 31/33/45/52/58). Compared with the qHPV vaccine, the 9vHPV vaccine potentially increases the coverage of protection from 70% to 90% of cervical cancers. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 9–15-year-old girls.

Methods: Participants (n = 600) were randomized to receive 9vHPV or qHPV vaccines on day 1, month 2 and month 6. Serology testing was performed on day 1 and month 7. HPV type-specific antibody titers (anti-HPV 6/11/16/18/31/33/45/52/58) were determined by competitive Luminex immunoassay and expressed as geometric mean titers and seroconversion rates. Vaccine safety was also assessed.

Results: The HPV 6/11/16/18 immune responses elicited by the 9vHPV vaccine were comparable with those elicited by the qHPV vaccine. All participants (except 1 for HPV 45) receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles, although the incidence of injection-site swelling was higher in the 9vHPV vaccine group.

Conclusions: In addition to immune responses to HPV 31/33/45/52/58, a 3-dose regimen of the 9vHPV vaccine elicited a similar immune response to HPV 6/11/16/18 when compared with the qHPV vaccine in girls aged 9–15 years. The safety profile was also similar for the 2 vaccines.

From the *Vaccine Research Centre, University of Tampere, Tampere, Finland; Children’s Hospital, Lund University, Lund, Sweden; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; §Vaccine Research Department, FISABIO-Public Health, Valencia, Spain; Department of Health Sciences, University of Genoa, IRCSS AOU San Martino-IST, Genoa, Italy; Department of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby, Denmark; **Sanofi Pasteur MSD, Lyon, France; and ††Merck & Co., Inc., Whitehouse Station, NJ.

Accepted for publication April 14, 2015.

This study was funded by Sanofi Pasteur MSD. T.V. has received payments in respect of Board membership (Sanofi Pasteur MSD) and Consultancy (GSK, Merck & Co., Novartis); N.B. has received payments in respect of Speaker Bureaux services (MEDA Sweden); P.V.D. acts as investigator for Merck vaccine trials conducted on behalf of the University of Antwerp, for which the University obtains research grants; J.D-.D. has received payments in respect of Consultancy (GSK) and Speaker Bureaux services (Pfizer); G.I. has received payments in respect of Board membership (Sanofi Pasteur MSD and GSK), meeting expenses (Sanofi Pasteur MSD and Pfizer) and research grants from (Sanofi Pasteur MSD, GSK, Pfizer and Novartis); The institution of L.K.P. (Aarhus University Hospital, Skejby, Denmark) has received research grants from Merck; A.L. is an employee of Merck & Co., Inc; C.T., S.T. and M.B. are employees of Sanofi Pasteur MSD.

Address for correspondence: Martine Baudin, MD, Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. E-mail: clinicaldevelopment@spmsd.com.

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