Table of Contents
- Trial data availability
- What the available study measured
- Study design and phase
- Participants and population
- Endpoints and assessments
- What cannot be confirmed from the source
Trial data availability
The source data provided for this request does not include a clinical trial record for HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS. Instead, the only trial shown is NCT05082285, a completed Phase 1 study in meningococcal infections, with several vaccine products listed as interventions.[1]
Because of this, any trial details in this article must be taken from the available study record only, and not from a rotavirus trial that was not included in the source material.[1]
What the available study measured
The available study was designed to evaluate the safety and reactogenicity of vaccine formulations. Reactogenicity means the short-term reactions that can happen after vaccination, such as local or general symptoms that are tracked closely in a trial.[1]
The study also measured the immune response using human serum bactericidal assay (hSBA), which is a lab test used to see whether blood can help kill specific bacteria. The trial planned to measure hSBA titres and geometric mean titres for meningococcal serogroups A, C, W, Y, and B indicator strains at several time points.[1]
Study design and phase
The study was an interventional trial, which means participants received study vaccines and then researchers measured the results. It was listed as Phase 1, an early stage of research that mainly looks at safety and early immune response.[1]
The trial status was Completed, and the enrollment was 703 participants.[1]
Participants and population
The brief summary shows that the study compared several meningococcal and related vaccine formulations, including MenABCWY-2nd Gen, MenABCWY-1st Gen, MenB vaccine, and MenACWY-TT vaccine.[1]
The source data does not provide detailed age limits, inclusion rules, or exclusion rules. It also does not confirm a rotavirus study population for HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS.[1]
Endpoints and assessments
The primary safety endpoints included the number and percentage of participants with solicited administration site and systemic events during the 7 days after each vaccination. Solicited events are symptoms or reactions that the study team asks about in a planned way.[1]
The study also tracked unsolicited adverse events, including medically attended adverse events, serious adverse events, adverse events leading to withdrawal, and adverse events of special interest during 30 days after each vaccination and throughout the study.[1]
For immune response, the trial measured the percentage of participants with hSBA titres at or above the lower limit of quantitation, along with hSBA geometric mean titres and geometric mean ratios at Day 91, Day 301, and Day 331. These are standard ways to summarize how strong the blood test response is across a group.[1]
What cannot be confirmed from the source
The source material does not provide a clinical trial entry for HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) PRODUCED ON VERO CELLS, so the study phase, condition studied, participant age range, and endpoints for that substance cannot be confirmed from the provided data.[1]
It is also not possible to confirm whether this substance was tested alone or as part of a combination vaccine from the information given here.[1]
