Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT02645032
Brief Summary:
This is a Phase I, Randomized, observer-blinded, age de-escalating study.
The study objectives are:
1. To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
2. To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
3. To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.
Detailed Description:
This study will be carried out in healthy adults and children at a single site. Subjects will be stratified according to age.
The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical history, physical examination and lab investigations. Collect blood for safety and immunogenicity assessments.
Visit 2 (day 0): Enroll, randomize and administer first dose of vaccine to eligible participants
Visit 3 (day 3): Assess participant safety by medical history and physical examination
Visit 4 (day 7): Record solicited adverse reaction 7 days post vaccination, and collect blood for safety lab assessments.
Visit 5 (day 28): Assess participant safety, collect blood for immunogenicity assessments, and administer second vaccine dose
Visit 6 (day 31): Participants safety will be assessed by medical history and physical examination
Visit 7 (day 35): Record solicited adverse reaction 7 days post second vaccination.
Visit 8 (day 56): Collect blood for immunogenicity assessments, assess participant safety, and fill in study completion form in the absence of any safety concern.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator.
Study:
NCT02645032
Study Brief:
Protocol Section:
NCT02645032