Table 1.
Characteristics of included published studies, reporting findings from randomized, controlled trial on 9vHPV
| Reference | Trial's NCT number | Study design | Study site | Study period | Study population | Sample size* | Follow up | Intervention | Comparison | Assessed outcomes | Analysis |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Joura et al. [34] | NCT00543543 | Phase III Randomized, double-blind controlled trial |
Multicenter 18 countries | September 2007–April 2013 | Females, 16–26 years | 14215 | 54 months | 9vHPV (3 doses at 0, 2, and 6 months) | qHPV (3 doses at 0, 2, and 6 months) | EFFICACY IMMUNOGENICITY SAFETY | Modified intention-to-treat: efficacy Per-protocol for all assessed outcomes |
| Luxembourg et al. [38] | NCT00543543 | Three Phase II Randomized, double-blind controlled trials (Study 1, Study 2, Study 3) |
Multicenter Study 1:3 countries Study 2:7 countries Sudy 3:5 countries |
Study 1: December 2005–August 2007 Study 2: September 2007–April 2013 Study 3: October 2007–May 2009 |
Females, 16–26 years | Study 1: 680 Study 2: 1242 Sudy 3: 623 |
Study 1: 7 months Study 2: 3 months Study 3: 7 months |
Study 1: 8vHPV Study 2: 9vHPV (low-, mid-, and high-dose form.) Sudy 3: qHPV + 5vHPV Study 1, 2, and 3: (3 doses at 0, 2, and 6 months) |
Study 1, 2, and 3: qHPV (3 doses at 0, 2, and 6 months) | IMMUNOGENICITY SAFETY | Per-protocol for all assessed outcomes |
| Luxembourg et al. [39] | NCT00943722 | Phase III Randomized, double-blind controlled trial |
Multicenter 17 countries | (not reported) | Females, 9–15 years | 1935 | 7 months | 9vHPV (3 doses at 0, 2, and 6 months) | 9vHPV (3 doses at 0, 2, and 6 months) | IMMUNOGENICITY (lot consistency study, 3 lots) | Per-protocol |
| Van Damme et al. [42] | NCT00943722 | Phase III Randomized, double-blind controlled trial |
Multicenter 17 countries | August 2009–April 2013 | Females, 16–26 years females and males 9–15 years | 3074 | 7 months | 9vHPV (3 doses at 0, 2, and 6 months) in females, 16–26 years | 9vHPV (3 doses at 0, 2, and 6 months) in females and males 9–15 years | IMMUNOGENICITY SAFETY (adult–adolescent immunobridging study) ANTIBODY PERSISTANCE |
Per-protocol for all assessed outcomes |
| Schilling et al. [40] | NCT00988884 | Randomized, double-blind controlled trial | Multicenter 4 countries | October 2009–February 2011 | Males and females, 11–15 years | 1241 | 8 months | 9vHPV (3 doses at 0, 2, and 6 months) + concomitant MCV4/Tdap (1 dose at 0 month) | 9vHPV (3 doses at 0, 2, and 6 months) + non-concomitant MCV4/Tdap (1 dose at 1 month) | IMMUNOGENICITY SAFETY | Per-protocol for all assessed outcomes |
| Garland et al. [36] | NCT01047345 | Randomized, double-blind controlled trial | Multicenter 8 countries | February 2010–June 2011 | Females, 12–26 years who previously received a qHPV three-dose regimen | 924 | 7 months | 9vHPV (3 doses at 0, 2, and 6 months) | Placebo | IMMUNOGENICITY SAFETY | Per-protocol for all assessed outcomes |
| Kosalaraksa et al. [37] | NCT01073293 | Randomized, double-blind controlled trial | Multicenter 6 countries | April 2010–June 2011 | Males and females, 11–15 years | 1054 | 8 months | 9vHPV (3 doses at 0, 2, and 6 months) + concomitant Tdap-IPV (1 dose at 0 month) | 9vHPV (3 doses at 0, 2, and 6 months) + non-concomitant Tdap-IPV (1 dose at 1 month) | IMMUNOGENICITY SAFETY | Per-protocol for all assessed outcomes |
| Vesikari et al. [43] | NCT01304498 | Phase III Randomized, double-blind controlled trial | Multicenter 6 countries | February 2011–May 2011 | Females, 9–15 years | 600 | 7 months | 9vHPV (3 doses at 0, 2, and 6 months) | qHPV (3 doses at 0, 2, and 6 months) | IMMUNOGENICITY SAFETY | Per-protocol for all assessed outcomes |
| Castellsagué et al. [35] | NCT01651949 | Randomized, double-blind controlled trial | Multicenter 17 countries | October 2012–August 2014 | Females, 16–26 years Males 16–26 years |
2520 | 7 months (12 months safety) | 9vHPV (3 doses at 0, 2, and 6 months) in heterosexual males 16–26 years and men having sex with men 16–26 years | 9vHPV (3 doses at 0, 2, and 6 months) in females, 16–26 years | IMMUNOGENICITY SAFETY (females–males immunobridging study) | Per-protocol for all assessed outcomes |
| Van Damme et al. [41] | NCT02114385 | Phase III Randomized, double-blind controlled trial |
Multicenter 3 countries | March 2014–April 2015 | Males 16–26 years | 500 | 7 months | 9vHPV (3 doses at 0, 2, and 6 months) | qHPV (3 doses at 0, 2, and 6 months) | IMMUNOGENICITY SAFETY | Per-protocol for all assessed outcomes |
9vHPV, human papillomavirus 9-valent vaccine; 8vHPV, HPV 8-valent vaccine; 5vHPV, HPV 5-valent vaccine; qHPV, HPV quadrivalent vaccine; MCV4, meningococcal A/C/Y/W-135 vaccine; Tdap, tetanus, diphtheria, acellular pertussis vaccine; Tdap-IPV, diphtheria, tetanus, pertussis, and poliomyelitis vaccine; Pap test, Papanicolaou test; Yrs, years; Dose form., dose formulations.
*
Subjects who underwent randomization.