Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT06955728
Description:
Progress reports for this trial will be made available to the trial funder, ethics committees, regulatory authorities and other stakeholders. Final trial results will be shared with the same stakeholders within 3 months of final lock of the trial database. Study data will be shared with Pfizer in the event of safety concerns or a request from a regulatory agency. Manuscript(s) will be prepared and submitted for peer-review in open access journals. All proposed publications will first be reviewed by Pfizer prior to publication for review of potential confidential information. A publication plan and proposal for criteria of authorship will be established with the sites. The trial database will be made publicly available upon request. Any transfer of data, will be governed, by the terms of the local Ethics Committee (HREC).
Study:
NCT06955728
Study Brief:
A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.