PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT)

Informations projet

PROTECT

N° de convention de subvention: 101145724

DOI

10.3030/101145724

Date de signature de la CE 27 Février 2024

Date de début 1 Mars 2024

Date de fin 28 Février 2027

Financé au titre de

• Health

Coût total

€ 3 271 990,50

Contribution de l’UE

€ 3 271 990,50

Coordonné par

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA
Spain

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Livrables

Documents, reports (18)

Plan for the exploitation and dissemination of results including communication activities

Development DEC plan for dissemination, exploitation and communication measures

Draft stewardship plan

Draft stewardship plan all WPs

SOPs and Training Plan

Development SOPs (sepsis consensus definition, sample collection/analysis), Training Plan

Charters of advisory bodies

Terms of Reference (ToR) of Advisory Bodies

Study initiation package WP2

Registration number clinical study, final version study protocol, ethics approval

GBS Surveillance harmonised protocol

Development surveillance study harmonized protocol, and CRFs for data collection

Study initiation package WP3

Registration number clinical study, final version study protocol, ethics approval

Updated plan for the exploitation and dissemination of results including communication activities

Update of the DEC plan for dissemination, exploitation and communication measures

Management SOPs

Development SOPs management structure, workflows and procedures

Statistical analytical plan

Development statistical analytical data from site sentinel GBS surveillance

Core outcome measures (AESI/AEFI)

Consensus report of core AESI/AEFI of interest for maternal vaccine trials

Social media toolkit & guide

Guide to social media platforms for coherent and timely communication

Stakeholder mapping

Report of relevant national and international stakeholders

EHR scoping review AEFI/AESI monitoring

Review of existing EHR to establish their operations and gaps to inform the proposed PER

A situational analysis report

Report factors influencing willingness to participate in maternal vaccine trials

Laboratory manual sample analysis

Development laboratory manual for handling, processing and analysis of samples

Dissemination toolkit

Professional corporate identity: project logo/style guide, dissemination/marketing materials

Protocol

Development of the final study protocol approved by regulators

Other (6)

Project Intranet

Development intranet for document storage, file sharing and up-to-date overview project status

Data linkage tools to existing datasets

Identifying identifiers for data linkage maternal/infant datasets and developing linkage codes

Study registration

Registration on clinicaltrials.gov

Algorithms for data abstraction in EHR

Reviewing and adapting data extraction codes

Ethical approvals

Ethical review and approvals by relevant regulatory bodies

Project Website

Data Management Plan (2)

Updated Data Management Plan

Updated DMP for data entry, cleaning and handling

Data Management Plan

Development DMP for data entry, cleaning and handling.