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Clinical Trials
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
When all the necessary approvals are in place, the trial can be formally initiated in each participating centre,. Patients can be enrolled, treated and followed up according to the specifications in the CTP. During the trial, the trial procedures and the data collected need to be monitored by a person with adequate training for that function. Monitoring is a GCP requirement, with the objective of ensuring that patients’ rights and well-being are protected, the reported data is complete and accurate, and the conduct of the trial in accordance with the CTP. Once treatment and follow-up of the patients in the trial is completed, data is cleaned, and the database locked before proceeding to data analysis. The results of the trial are summarized in a final clinical study report (CSR), which is sent to the regulatory authorities for filing. The publication of the results in peer-reviewed medical journals does not replace the need for a CSR. All the essential documents and data records for a clinical trial have to be archived for a minimum of 15 years by sponsor and sites.
Immune interference (blunting) in the context of maternal immunization with Tdap-containing vaccines: is it a class effect?
Published in Expert Review of Vaccines, 2020
Walid Kandeil, Miloje Savic, Maria Angeles Ceregido, Adrienne Guignard, Anastasia Kuznetsova, Piyali Mukherjee
Up to 1 March 2019, 13 studies in total were identified and reviewed, which were conducted in different settings and included different Tdap-containing vaccines for maternal immunization and different DTaP-containing vaccines for infant primary/booster vaccination series. The list of studies and study details including gestational week of maternal vaccination and vaccine brands used, pediatric immunization schedule and vaccines used are summarized in Table 1, along with the quality assessment of the studies. Details on the measured geometric mean antibody concentration (GMC) levels and the percentage of seroprotected (defined by internationally agreed correlates of protection) or seropositive infants are summarized in Table 2 and Supplementary Table 1. A schematic summary of the antibodies evaluated in the reviewed studies is provided in Supplementary Table 2. Four studies evaluated immune responses after primary and booster vaccination [15–17,20,25,27], 7 after primary vaccination [21–24,28–30] and 2 after booster vaccination [19,31]. Of note, the primary and booster vaccination results of two studies (in Belgium [19,28] and Vietnam [24,31]) are described in separate publications. For one of the GSK-sponsored clinical trials, the included results are from an exploratory analysis of a multicenter randomized clinical trial and are unpublished but a link is provided to the primary publication [16], abstract [15] and full clinical study report publicly available on the GSK study register [17].