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An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine Given Concomitantly With Diphtheria, Tetanus, Pertussis, and Poliomyelitis Vaccine in Healthy Adolescents 11 to 17 Years of Age

Vesikari, Timo MD*; Van Damme, Pierre MD, PhD†; Lindblad, Niklas MD‡; Pfletschinger, Ulrich MD§; Radley, David MS¶; Ryan, Desmond BS¶; Vuocolo, Scott PhD¶; Haupt, Richard M. MD¶; Guris, Dalya MD¶

Pediatric Infectious Disease Journal: April 2010 - Volume 29 - Issue 4 - pp 314-318
doi: 10.1097/INF.0b013e3181c177fb
Original Studies

Background: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and poliomyelitis vaccine).

Methods: This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences.

Results: Immune response for all GARDASIL antigens following concomitant administration of the vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group.

Conclusion: Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either vaccine. Concomitant administration of vaccines would minimize the number of visits required to deliver each vaccine individually.

From the *Vaccine Research Centre, University of Tampere Medical School, Tampere, Finland; †Center for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; ‡Department of Otorhinolaryngology, Turku University Hospital, Turku, Finland; §Pediatric offices, Stuttgart, Germany; and ¶Merck & Co., Inc., Upper Gwynedd, PA.

Accepted for publication September 16, 2009.

Supported by Merck Research Laboratories, a Division of Merck & Company, Inc.

T. Vesikari has received funding through his institution to conduct HPV vaccine studies for Merck, and has also received advisory board fees from Merck. P. Van Damme acts as principal investigator for clinical trials conducted on behalf of the University of Antwerp, for which the University obtains research grants from Merck and GlaxoSmithKline; speakers fees for presentations on vaccines are paid directly to an educational fund held by the University. D. Guris, R. Haupt, D. Radley, D. Ryan, and S. Vuocolo are employees of Merck and potentially own stock and/or stock options in the company.

The study was designed by the sponsor (Merck and Co, Inc.). The sponsor collated the data, monitored the conduct of the study, performed the statistical analysis, and coordinated the writing of the manuscript with all authors. The authors were actively involved in the collection, analysis, or interpretation of the data; the revising of the manuscript for intellectual content; and approved the final manuscript.

Address for correspondence: Timo Vesikari, MD, Vaccine Research Centre, University of Tampere Medical School, Tampere, Finland. E-mail: timo.vesikari@uta.fi.

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© 2010 Lippincott Williams & Wilkins, Inc.