Malaysian trial (ph3,2v).
Methods | Phase IIIb, double‐blind, randomised controlled trial | |
Participants | 271 women (135 in the vaccine arm and 136 in the placebo arm) from Malaysia Age range: women aged 18 to 35 years Inclusion criteria: women who were healthy Exclusion criteria: women who had HPV vaccine, chronic use of immunosuppressants, history of allergy to vaccine compounds, history of chronic conditions of cancer and autoimmune disease, acute disease, pregnant |
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Interventions | Vaccine: HPV16/18 AS04‐adjuvant bivalent vaccine Placebo: aluminium hydroxide as placebo |
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Outcomes | Safety and immunogenicity | |
Notes | Report: Lim 2014 Last report average follow‐up time: 7 months after first dose |
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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 | A single treatment number was used for each patient uniquely identify the doses administered to the 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 |