| Moreira et al.3434 Moreira ED Jr, Palefsky JM, Giuliano AR, et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Hum Vaccines. 2011;7:768-75. (2011/5) |
ECR, DC, CP |
HPV QV (n=1945) vs. Placebo (n=1950) |
M (16‐26a) |
Dor local |
| Kim et al.,2323 Kim YJ, Kim KT, Kim JH, et al. Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10–14 years. J Korean Med Sci. 2010;25:1197-204. (2010/5) |
ECR |
HPV BV (n=474) vs. Vacina hepatite A (n=483) |
F (10‐14a) |
Dor local, eritema, edema e mialgia |
| Sow et al.3535 Sow PS, Watson-Jones D, Kiviat N, et al. Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10–25-year-old HIV seronegative African girls and young women. J Infect Dis. 2013;207:1753-63. (2013/5) |
ECR IIIb, DC, CP, MULTI (hidróxido de alumínio) |
HPV BV (n=1298) vs. Placebo (n=643) |
F (10‐25a) |
Dor local |
| Reisinger et al.3636 Reisinger KS, Block SL, Lazcano-Ponce E, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007;26:201-9. (2007/5) |
ECR, DC, CP |
HPV QV (n=1165) vs. Placebo (n=584) |
M e F (1:1) (9‐15a) |
Dor local, eritema e edema |
| Szarewski et al.3737 Szarewski A, Poppe WA, Skinner SR, et al. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15–25 years with and without serological evidence of previous exposure to HPV-16/18. Int J Cancer. 2012;131:106-16. (2012/5) |
ECR, DC |
HPV BV (n=9319) vs. Vacina hepatite A (n=9325) |
F expostos HPV (15‐25a) |
Dor local, eritema e edema |
| Petäjä et al.3838 Petäjä T, Keränen H, Karppa T, et al. Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10–18 years. J Adolesc Health. 2009;44:33-40. (2009/3) |
ECR, fase I/II, observador cego |
HPV BV (n=181) vs. Vacina hepatite B (n=89) |
M (10‐18a) |
Dor local, edema e mialgia |
| FUTURE II3333 The FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356:1915-27. (2007/5) |
ECR, DC, CP |
HPV QV (n=448) vs. Placebo (n=447) |
F (15‐26a) |
Dor local, alergia sazonal |
| Medina et al.3939 Medina DM, Valencia A, de Velasquez A, et al. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomized, controlled trial in adolescent girls. J Adolesc Health. 2010;46:414-21. (2010/3) |
ECR, MULTI |
HPV BV (n=1017) vs. Vacina hepatite A (n=1010) |
F (10‐14a) |
Dor local, eritema, edema, cefaleia, mialgia, fadiga, urticária e síncope |
| Romanowski et al.4040 Romanowski B, Schwarz TF, Ferguson LM, et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccines. 2011;7:1374-86. (2011/3) |
ECR fase I/II, PC; 2 vs. 3 doses de HPV bivalente |
2 doses FOR20/20 M0/6 (n=240); 2 doses FOR40/40 M0/6 (n=241); 2 doses FOR40/40 M0/2 (n=240); 3 doses FOR20/20 0/1/6 (n=239) |
F (9‐25a) |
– |
| Garland et al.3232 Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007;356:1928-43. (2007/5) |
ECR, DC, CP, MULTI |
HPV QV (n=2673) vs. Placebo (n=2672) |
F (16‐24a) |
Dor local, eritema, edema e prurido local, febre >38,9°C broncoespasmo |
| Petäjä et al.4141 Petäjä T, Pedersen C, Poder A, et al. Long-term persistence of systemic and mucosal immune response to HPV-16/18 AS04-adjuvanted vaccine in preteen/adolescent girls and young women. Int J Cancer. 2011;129:2147-57. (2011/3) |
ECR fase III, MULTI |
HPV BV (n=616) |
F (10‐25a) |
– |
| Esposito et al.4242 Esposito S, Birlutiu V, Jarcuska P, et al. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared with the standard dosing schedule in healthy women aged 15 to 25 years: results from a randomized study. Pediatr Infect Dis J. 2011;30:e49-55. (2011/3) |
ECR, esquema padrão 0/1/6 m) vs. alternativo (0/1/12 m) |
HPV BV Padrão (n=1195) vs. HPV BV Alternativo (n=1188) |
F (15‐25a) |
– |
| Kang et al.4343 Kang S, Kim KH, Kim YT, et al. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2007;18:1013-9. (2008/5) |
ECR, DC, CP |
HPV QV (n=117) vs. Placebo (n=59) |
F (9‐ 23a) |
Dor local, eritema, edema e febre |
| Li et al.4444 Li R, Li Y, Radley D, et al. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females. Vaccine. 2012;30:4284-91. (2011/3) |
ECR, DC, CP |
HPV QV (n=302) vs. Placebo (n=298) |
M (9‐15a) e F (9‐45a) |
Dor local, edema e prurido |
