Table of contents
- Trial data availability
- Available study overview
- Population and setting
- What was measured
- Trial status and phase
Trial data availability
The source data provided for this article does not include a clinical trial record for ROTAVIRUS SEROTYPE G2 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS. The only trial shown in the source is a different study about meningococcal immunization in children, toddlers, and infants.[1]
Available study overview
The available study is titled “Safety and immunogenicity of an investigational Pentavalent Meningococcal ABCYW vaccine against meningococcal disease in children, toddlers, and infants.”[1] It is an interventional study, which means researchers give study vaccines and then measure the effects.[1] The study is in Phase 2 and is listed as Authorised.[1]
The study brief says its main goals are to describe the safety profile of MenPenta vaccine formulations in healthy children, toddlers, and infants, and to describe the immune response after vaccination.[1] In infants, immune response is measured 30 days after the second dose given at about 4 months of age and again after the third dose given at 12 to 15 months of age.[1] In children and toddlers, immune response is measured at each time point after vaccination.[1]
Population and setting
The study plans to include 750 participants.[1] The target groups are healthy children, toddlers, and infants.[1] The brief also describes three stages: Stage 1 for children, Stage 2 for toddlers, and Stage 3 for infants.[1]
The interventions listed in the source include several vaccines used for comparison, such as Hexyon, MenQuadfi, RotaTeq, Bexsero, Prevenar 13, and Nimenrix, along with MenPenta SD and MenPenta fHD.[1] These names appear in the source as study products or comparators, but the provided data does not give a rotavirus trial for the requested substance.[1]
What was measured
The main outcomes focus on adverse events, which are health problems seen during a study, whether or not they are caused by the vaccine.[1] The study measures unsolicited immediate adverse events, solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events.[1]
The study also measures immune response with hSBA, which is a lab test that checks whether blood can help kill bacteria.[1] For infants, the outcomes include antibody titers, seroresponse, geometric mean titers, and the percentage of participants with results at or above the lower limit of quantification for meningococcal groups A, C, W, Y, and B reference strains.[1] For children and toddlers, similar immune measures are listed for the same meningococcal groups and reference MenB strains.[1]
Trial status and phase
The study status is Authorised, and the phase is Phase 2.[1] Phase 2 studies are usually used to learn more about safety and early signs of how well a vaccine works.[1] Because the source data does not contain a rotavirus trial record, no study phase, endpoint, or participant detail can be reported for ROTAVIRUS SEROTYPE G2 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS from the provided material.[1]
