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• W1973598647 abstract "1 Stiftung Juliusspital Wurzburg, Wurzburg, Germany 2 Hospital Materno-Infantil La Paz, Madrid, Spain 3 Instituto Hispalense de Pediatŕia, Sevilla, Spain 4 Centre Medical de l’Institut Pasteur, Paris, France 5 Cabinet Medical Tran, Nice, France 6 Praxis, Hamburg, Germany 7 Medizinische Hochschule Hannover Allg. Gynakologie und Geburtshilfe, Hannover, Germany 8 GlaxoSmithKline Biologicals, Rixensart, Belgium Background: CervarixTM (GlaxoSmithKline), AS04 adjuvanted cervical cancer vaccine, has been shown to be safe, immunogenic and highly effective for the prevention of persistent human papillomavirus (HPV)-16/18 infection and associated precancerous lesions in girls and women aged 15—25 years. Since many countries recommend HPV vaccination in adolescents when other pediatric and adolescent vaccines are routinely administered, coadministration of CervarixTM with other vaccines will be convenient for physicians and vaccinees. This study (108464/NCT00426361) evaluated the immunogenicity and safety of CervarixTM co-administered with BoostrixTM Polio (dTpa-IPV, GlaxoSmithKline) a diphtheria-tetanus-acellular pertussis-inactivated polio vaccine. Methods: Healthy girls aged 10—18 years were randomized in 3 groups to receive either HPV-16/18 vaccine alone (HPV-16/18 group; n = 248), HPV-16/18 co-administered with dTpa-IPV (HPV16/18+dTpa-IPV group; n = 252), or dTpa-IPV vaccine alone (n = 251). Immunogenicity (ATP) and safety were assessed 1 month after the first vaccine dose. Results: Interim data on immunogenicity and safety 1 month after the first dose are presented. Co-administration of HPV-16/18 and dTpa-IPV was demonstrated non-inferior to separate administration of dTpa-IPV, with seroprotection rates of 99.6% for anti-diphtheria and 100% for anti-tetanus antibodies in both groups. Seropositivity rates for anti-pertussis and seroprotection rates for anti-poliovirus type antibodies were ≥98.7% and 100%, respectively, in the HPV-16/18+dTpa-IPV group and ≥96.5% and ≥99.6% in the dTpa-IPV group. Seroconversion rates for anti-HPV 16 and 18 antibodies in initially seronegative subjects were 100% in the HPV-16/18 group and 99.1% in the HPV-16/18+dTpa-IPV group. Post-vaccination GMTs in HPV-16/18+dTpa-IPV group were similarly high as for respective antigens in the HPV-16/18 and dTpa-IPV groups. Co-administration of the two vaccines was generally well-tolerated. No subjects withdrew due to adverse events and no vaccine-related serious adverse events were reported. Conclusion: Results from this interim analysis show that the co-administration of CervarixTM with BoostrixTM Polio does not affect the immune response to each individual vaccine, and is well-tolerated." @default.
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• W1973598647 date "2008-12-01" @default.
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• W1973598647 title "Co-Administration of GSK's AS04 Adjuvanted Cervical Cancer Vaccine with Combined dTpa-IPV Vaccine in Girls Aged 10–18 Years" @default.
• W1973598647 doi "https://doi.org/10.1016/j.ijid.2008.05.372" @default.
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