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REACTOGENICITY OF GLAXOSMITHKLINE’S AS04-ADJUVANTED CERVICAL CANCER VACCINE CO-ADMINISTERED WITH COMBINED DIPHTHERIA–TETANUS–ACELLULAR PERTUSSIS-INACTIVATED POLIOVIRUS VACCINE IN GIRLS AGED 10–18 YEARS
  1. T F Schwarz1,
  2. J Garcia-Sicilia2,
  3. A Carmona3,
  4. J E Malkin4,
  5. M P Tran5,
  6. K Peters6,
  7. P Hillemanns7,
  8. F Thomas8,
  9. D Descamps8,
  10. G Dubin9
  1. 1Stiftung Juliusspital Wuerzburg, Wuerzburg, Germany
  2. 2Hospital Materno-Infantil La Paz, Madrid, Spain
  3. 3Instituto Hispalense de Pediatria, Sevilla, Spain
  4. 4Centre Medical de l’Institut Pasteur, Paris, France
  5. 5Cabinet Medical Tran, Nice, France
  6. 6Praxis, Hamburg, Germany
  7. 7Klinik fuer Frauenheilkunde und Geburtshilfe, Medizinische Hochschule Hannover, Hannover, Germany
  8. 8GlaxoSmithKline Biologicals, Rixensart, Belgium
  9. 9GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania, USA

Abstract

Background As many countries recommend human papillomavirus (HPV) vaccination in adolescent girls at an age when other vaccines are routinely administered, co-administration of this vaccine with other adolescent vaccines would be convenient. This study (108464/NCT00426361) evaluated the reactogenicity of HPV-16/18 AS04 adjuvanted vaccine (Cervarix, GlaxoSmithKline) co-administered with diphtheria–tetanus–acellular pertussis-inactivated poliovirus vaccine (dTpa-IPV; Boostrix Polio, GlaxoSmithKline).

Methods Healthy girls aged 10–18 years were randomly assigned to three groups to receive either HPV-16/18 (n  =  246), dTpa-IPV (n  =  250), or HPV-16/18 vaccine co-administered with dTpa-IPV (n  =  250). Solicited local and general symptoms were recorded for 7 days post-vaccination. Unsolicited symptoms, serious adverse events (SAE), medically significant conditions and new onset of chronic diseases are assessed during the entire study period and reported up to one month post-dose 1.

Results Incidence of local solicited symptoms was 25.2–85.0% in the HPV-16/18 group, 30.0–84.0% in the dTpa-IPV group and 31.6–89.2% in the HPV-16/18 plus dTpa-IPV group (grade 3 severity ⩽6.1%, ⩽4.4% and ⩽8.8%, respectively). Respective incidences of most common general solicited symptoms were: fatigue, 29.7%, 35.6%, 41.2%; headache, 29.7%, 33.2%, 38.0%; myalgia, 28.9%, 35.2%, 38.4%. Incidence of grade 3 general solicited symptoms was low in all groups (⩽1.2%, ⩽2.8% and ⩽3.6%, respectively). Respective incidence of unsolicited symptoms was 22.2%, 23.5% and 17.5%. No subjects withdrew due to adverse events and no vaccine-related SAE were reported.

Conclusions Cervarix has similar reactogenicity to Boostrix Polio, another adolescent vaccine licensed and in general use. Co-administration of these two vaccines was generally well tolerated and did not increase the frequency of solicited local and general symptoms.

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