Study Documents

Patient Information

The documents below provide information for both young people and adults who wish to be involved in PICOBOO. You will be asked to read these and provide consent if you wish to enrol in the study.

PICOBOO Study Participant Information Sheet
Adult Consent Form
PICOBOO study Adolescent and Parent/Guardian Participant Information Sheet
Adolescent/Parent/Guardian Consent Form
Adult Participant Information Sheet for Re-Randomisation
Adult Consent Form for Re-Randomisation

Study Protocols

The study protocol for PICOBOO is separated into distinct sections. This structure was chosen to standardise the processes within the sub-studies and to minimise duplication. It is anticipated that the core protocol, statistical appendix and laboratory appendix will require infrequent updates compared to the SSPs.

Each section of the current study protocol is available to download below.

The Core Protocol – outlines the general study processes that are applicable to all PICOBOO participants. This includes the study design, the requirements for safety monitoring and the methods for randomisation, data collection and analysis.

Core Protocol

Sub-study Specific Protocol (SSP) – An SSP will be written for each vaccination schedule, for example, one SSP will be written for booster vaccination. It is anticipated that further SSP’s will be developed as new vaccination schedules arise. The SSP describes specific information such as the inclusion/exclusion criteria and the description and timing of study activities for the participant.

Sub-Study Protocol 1 – Booster Vaccination

The Statistical Appendix – this is a high-level statistical document which specifies how analyses will be conducted and summarises the initial simulations conducted by the team.

Statistical Appendix

The Laboratory Appendix – describes the laboratory assays that will be performed on the biological samples collected during the PICOBOO trial.

Laboratory Appendix

The Trial Simulations – this is a statistical document containing the initial trial simulations conducted by the team.

Trial Simulations