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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT04626856
Brief Summary:
This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.
Detailed Description:
This clinical trial aimed to evaluate safety and immunogenicity effect of IRV（Vero cell）in Chinese healthy adults, adolescents and infants. The subjects were divided into 5 groups. Two dose and three dose levels will be evaluated. Adult (aged 18-49 years), adolescents (aged 6-17 years), infant subjects (aged 7-71 months) and infant subjects (aged 2-6 months) will receive intramuscular (IM) injection on Days 0 and 28. Infant subjects (aged 2-6 months) subjects will receive intramuscular (IM) injection on Days 0 , 28 and 56. Three dose subgroups (low dose, medium dose and high dose were included in each age group. To maintain blindness in the trial, subjects were randomized in a 3:1 ratio to receive different dosages of the vaccine group or placebo group. In the analysis, the placebo subjects of the same age group were combined to ensure that the analysis ratio of the experimental vaccine group to the placebo group is 1:1. Therefore, 24 subjects in the experimental vaccine group and 8 subjects in the placebo group were chose in each dose group. Subjects were randomized to receive different dosages of the vaccine or placebo. Vaccination was performed in the adult group first, then on the adolescents, and on the infants last. Within each age group, dose-escalation with the principle from low to high dosage.
Study:
NCT04626856
Study Brief:
Protocol Section:
NCT04626856