Indian trial (ph3,2v).
Methods | Phase III, double‐blind, randomised, controlled and multicentre trial | |
Participants | 354 women (176 in the vaccine arm and 178 in the placebo arm) from Hong Kong Age range: women aged 18 to 35 years Inclusion criteria: healthy women not taking any other investigational products or steroids and not pregnant or planning to become pregnant |
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Interventions | Vaccine: HPV16/18 AS04‐adjuvant bivalent vaccine Placebo: visually indistinguishable aluminium‐containing placebo |
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Outcomes | Safety and immunogenicity | |
Notes | Last report average follow‐up time: 7 months (Indian trial (ph3,2v)) | |
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 SAS analysis system |
Allocation concealment (selection bias) | Low risk | Throughout the study, a single treatment number was used to uniquely identify the vaccine doses to be given to the same participant |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described in the paper |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described in the paper |
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 |