Korean trial (ph3,2v).
Methods | Phase III randomised, double‐blind, placebo‐controlled trial | |
Participants | Participants: 321 females (160 in the vaccine arm and 161 in the placebo arm) Age range: 10 to 14 years. Inclusion criteria: include healthy Korean women who were using no other investigational products or immune‐modifying drugs, not pregnant or planning to become pregnant, not breastfeeding during the study. Use effective contraception or abstinent from sexual relations Exclusion criteria: women who had received previous HPV vaccination |
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Interventions | Vaccine: HPV16/18 bivalent vaccine Placebo: hepatitis A vaccine |
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Outcomes | Immunogenicity and safety outcomes | |
Notes | Main report: Kim 2010; Last report average follow‐up time: 7 months |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly allocated to two groups in a 1:1 ratio using an Internet‐based randomisation system |
Allocation concealment (selection bias) | Low risk | Syringes were prepared and administered by qualified medical personnel not otherwise involved in the study |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | See above |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The assessment of symptoms were conducted by personnel not involved in study |
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 |