Chinese trial (ph3,2v)_young.
Methods | Phase II/III randomised, double‐blind, controlled trial | |
Participants | Participants: 3819 women (3026 in the vaccine arm and 3025 in the placebo arm) enrolled at four sites in JiangSu Province Age range: 18 to 25 years Inclusion criteria: women were agreed to use contraceptive precautions 30 days before the 1st vaccine dose and 2 months after completion of the vaccine series Exclusion criteria: women who were pregnant or breastfeeding, had an immunosuppressive or immunodeficient condition, a history of colposcopy, an allergic disease likely to be exacerbated by any component of the vaccine or previously received HPV vaccination or adjuvant were excluded |
|
Interventions | Vaccine: bivalent vaccine Placebo: aluminium hydroxide placebo |
|
Outcomes | Efficacy (incident and persistent HPV infection, CIN), safety and immunogenicity outcomes | |
Notes | Report: Zhu 2014. Follow‐up of 15 months |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Women were randomised in a 1:1 ratio with an Internet‐based centralised randomisation system |
Allocation concealment (selection bias) | Low risk | Treatment allocation at the investigation site were using an Internet‐based system |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All participants, investigators and study staff were blinded to individual participant treatment assignments and results |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All participants, investigators and study staff were blinded to individual participants treatment assignments and results |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes (safety and immunogenicity) were reported on the total vaccinated cohort. Reason for exclusion was noted and balanced between vaccine group and placebo group |
Selective reporting (reporting bias) | Low risk | All outcomes (safety and immunogenicity) were presented |