Table 4.
Summary of incidence of new sexual partners and chlamydia or gonorrhea among male and female clinical trial participants in the current study and in other studies of HPV vaccines.
| Study | New sexual partners | Chlamydia | Gonorrhea | |||
|---|---|---|---|---|---|---|
| n | Rate per | n | Rate per | n | Rate per | |
| person-yeara | 100 person-years | 100 person-years | ||||
| (95% CI) | (95% CI) | (95% CI) | ||||
| Current study (PPE population)b | ||||||
| Females (N = 971) | 520 | 0.73c | 792 | 2.52d | 792 | 0.57d |
| (0.69–0.77) | (1.94–3.22) | (0.32–0.94) | ||||
| Males (N = 301) | 162 | 1.05c | 236 | 2.58d | 236 | 0.66d |
| (0.97–1.14) | (1.55–4.03) | (0.21–1.53) | ||||
| 9vHPV vaccine study in womene | ||||||
| 9vHPV vaccine arm (N = 7099) | 6738 | 0.38 | 6871 | 2.9 | 6871 | 0.2 |
| (0.37–0.39) | (2.7–3.2) | (0.1–0.2) | ||||
| qHPV vaccine arm (N = 7105) | 6750 | 0.38 | 6860 | 2.9 | 6860 | 0.2 |
| (0.37–0.39) | (2.7–3.2) | (0.1–0.2) | ||||
| qHPV vaccine efficacy study in womenf | ||||||
| qHPV vaccine arm (N = 276) | 235 | 0.37 | 232 | 1.2 | 237 | 0.0 |
| (0.33–0.43) | (0.5–2.6) | (0.0–0.6) | ||||
| Placebo arm (N = 275) | 233 | 0.47 | 234 | 1.6 | 237 | 0.7 |
| (0.42–0.53) | (0.7–3.1) | (0.2–1.8) | ||||
| qHPV vaccine efficacy study in meng | ||||||
| qHPV vaccine arm (N = 2025) | 1772 | 1.21 | – | – | ||
| (1.17–1.24) | ||||||
| Placebo arm (N = 2030) | 1760 | 1.26 | – | – | ||
| (1.22–1.29) | ||||||
Abbreviations: 9vHPV = nine-valent human papillomavirus; LTFU = long-term follow-up; n = participants included in the analysis of new sexual partners; PPE = per-protocol effectiveness; qHPV = quadrivalent human papillomavirus.
Rate estimates obtained from a Poisson regression model of the number of new male and female sexual partners post-month 7, adjusted for follow-up time.
Baseline HPV-naïve population was approximated by the population of participants who were naïve for all of HPV types 6/11/16/18/31/33/45/52/58. The HPV-naïve analysis population in this analysis is comprised of participants who were PPE analysis population-eligible for all of HPV types 6/11/16/18/31/33/45/52/58.
For each participant, person-years follow-up was calculated starting from the date of sexual debut through the last visit with assessment of sexual history.
For each participant, person-years follow-up was calculated starting from the beginning of the LTFU study (i.e. month 42 visit) or the date when the participant reached 16 years of age, whichever came later.
NCT00543543 (see Huh et al., 2017 [5]).
NCT00365716 (see Villa et al., 2006 [22]).
NCT00090285 (see Giuliano et al., 2011 [21]).