Typhoid Clinical Trial
Official title:
A Randomized, Observer-Blinded, Phase I Study to Assess the Safety and Immunogenicity of Vi-DT Conjugate Vaccine Compared to Vi-Polysaccharide (Typhim Vi®, Sanofi Pasteur) Typhoid Vaccine in Healthy Filipino Adults and Children
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.
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.
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