Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in C… (NCT05032391) | Clinical Trial Compass
CompletedPhase 3
Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization
Russia100 participantsStarted 2019-02-22
Plain-language summary
The first multicenter prospective, randomized, double-blind, placebo-controlled clinical trial of the pentavalent live vaccine for RVI prevention was conducted in Russia among healthy infants aged 2 months at the time of the first vaccination.
Who can participate
Age range60 Days – 70 Days
SexALL
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Inclusion criteria
✓. Healthy male or female children at the age of 2 months at the time of the first vaccination with PI / PS, vaccinated according to age by the schedule of the National Calendar of Preventive Vaccinations of the Russian Federation;
✓. Baby should be ≥ 37 weeks gestational age and birth weight ≥ 2500 g;
✓. Children who do not have contraindications for vaccination (by the Protocol, according to medical history and clinical examination);
✓. An Informed Consent Form for participation in the research, voluntarily and personally signed by the parent / adoptive parent of the child, before any of the research procedures;
✓. Ability, in the researcher's opinion, of the parents / adoptive parents of the child to comply with the requirements of the Protocol (attendance of all scheduled Visits, completion of the Child Observation Diary, etc.).
Exclusion criteria
✕. Orphans (except for officially adopted children) and children without parental care;
✕. Child's gestational age \<37 weeks and birth weight \<2500 g;
✕. Participation in any other clinical study;
✕. Received or planned vaccination with any other rotavirus vaccine before enrollment in this study;
✕. A history of diarrhea or blood in the stool or a violation of bowel movements in the last 14 days;
✕
What they're measuring
1
Geometric mean concentration (GMC) of IgA antibodies
Timeframe: From 28 days post-Dose 3 to 1 year of age
2
Seroconversion rate
Timeframe: From 28 days post-Dose 3 to 1 year of age
3
Seroconversion factor
Timeframe: From 28 days post-Dose 3 to 1 year of age
4
Occurrence of unsolicited adverse events
Timeframe: Within the 31 days (Day 0 - Day 30) after the vaccine dose
5
Occurrence of serious adverse events
Timeframe: Within the 31 days (Day 0 - Day 30) after the vaccine dose
. A history of chronic diseases of the gastrointestinal tract, history of intussusception of the intestine and congenital malformations of the gastrointestinal tract, predisposing to it, surgery on the abdominal organs;
✕. Known sensitivity or allergy to any of the PI and PS components;
✕. Serious post-vaccination reactions/complications disorders/defects associated with any previous vaccinations;