Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenu… (NCT05037435) | Clinical Trial Compass
CompletedPhase 3
Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aidâ„¢ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.
Russia40 participantsStarted 2018-06-25
Plain-language summary
The purpose of the presented study was to evaluate the safety and immunological efficacy in preventing the rotavirus infection within a cohort of healthy subjects (target age of 18-45 years old) by using the pentavalent rotavirus vaccine - Rota-V-Aidâ„¢ (live attenuated oral, freeze-dried).
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. The signed informed consent;
✓. Healthy participants, men's and females aged from 18 up to 45 years inclusive;
✓. Readiness of participants and their sexual partners to use reliable methods of contraception (a combination of at least two modes, including one barrier method, for example, use of a spermicide and condom) from the moment of signing of the informed consent (that is in 3 days before administration of drugs) and before the expiration of 1 month after completion of participation in the study;
✓. The verified diagnosis "is healthy," established according to collecting the anamnesis and physical inspection:
✓. The Body Mass Index (BMI) is in normal limits (≥18.5 kg/sq.m and ≤30 kg/sq.m);
✓. There is a lack of instructions on alcohol abuse or narcotic dependence at the time of inclusion in study or the anamnesis;
✓. The participant's Ability, according to the study, to fulfill the requirements of the protocol.
Exclusion criteria
✕. The severe vaccine-challenged reactions/complications connected with the previous vaccination;
✕. Allergic reactions to components of vaccine or any previous vaccination;
✕. Any carried-out vaccination less than in 2 months before the present study;
✕. In the chronic anamnesis diseases of the digestive tract, causes intestinal invagination, gastrointestinal pathology, surgical interventions on abdominal organs;
What they're measuring
1
Geometric Mean Titer (GMT) of antibody
Timeframe: 28 days post-Dose 1
2
Seroconversion level
Timeframe: 28 days after Dose 1 of vaccine
3
Seroconversion factor (The increase in the geometric mean antibody titer on day 28 compared to the initial level is expressed in the fold increase.).
✕. Clinically significant deviations of laboratory and tool indicators (including standard pathological changes on the ECG) overstepping the bounds of the range of normal values revealed on screening and capable of negatively impacting the safety of participants of the volunteer in the study;
✕. Any diseases within four weeks preceding screening;
✕. Presence of any oncological diseases (including in the anamnesis);
✕. Any disease demands continuous therapy, including vegetable drugs or the expected concurrent therapy during the study;