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.
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.


CONCLUSIONS
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.
Vesikari
Timo
T
Vaccine Research Centre, University of Tampere Medical School, Tampere, Finland. timo.vesikari@uta.fi
Van Damme
Pierre
P
Lindblad
Niklas
N
Pfletschinger
Ulrich
U
Radley
David
D
Ryan
Desmond
D
Vuocolo
Scott
S
Haupt
Richard M
RM
Guris
Dalya
D
D000293:Adolescent; D052685:Alphapapillomavirus / Q000276:immunology; D000907:Antibodies, Bacterial / Q000097:blood*; D000914:Antibodies, Viral / Q000097:blood*; D001886:Bordetella pertussis / Q000276:immunology; D002648:Child; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000276:immunology; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D011051:Poliomyelitis / Q000276:immunology / Q000517:prevention & control; D023321:Poliovirus Vaccines / Q000008:administration & dosage / Q000276:immunology; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000276:immunology; D016896:Treatment Outcome; D014917:Whooping Cough / Q000276:immunology / Q000517:prevention & control
D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D004168:Diphtheria Toxoid; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D023321:Poliovirus Vaccines; D013745:Tetanus Toxoid