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ROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS

Clinical trials for ROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS are being studied in young children in a vaccine research setting. The trial data shown here focuses on safety and immune response, especially in infants, toddlers, and children. These trials look at how well the vaccine works and how well it is tolerated.

Table of contents

Trial overview

The source data provided for this article does not include a clinical trial that studies ROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS. Instead, the only trial listed is about meningococcal immunization in healthy young participants.[1]

This trial is an interventional study, which means researchers give vaccines and then measure the results.[1] The study compares MenPenta vaccine formulations with comparator vaccines and looks at both safety and immune response.[1]

Study population and participation

The trial includes healthy children, toddlers, and infants.[1] The brief summary says safety is described in children in Stage 1, toddlers in Stage 2, and infants in Stage 3.[1]

For infants in Stage 3, the study measures immune response after the second dose at about 4 months of age and after the third dose at 12 to 15 months of age.[1] For children and toddlers, immune response is measured at each time point after vaccination.[1]

Trial phase and status

The study is a Phase 2 trial.[1] Phase 2 studies are used to learn more about safety and how well the immune system responds in a larger group than early-stage trials.[1]

The status of the trial is Authorised, and the planned enrollment is 750 participants.[1]

Outcomes measured

The trial measures several safety outcomes, including unsolicited immediate adverse events, solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events.[1] These are used to see how well the vaccine is tolerated after vaccination.[1]

The trial also measures immune response using tests such as hSBA, vaccine seroresponse, and geometric mean titers for meningococcal serogroups A, C, W, Y, and reference MenB strains.[1] These tests check whether the body makes antibodies that may help protect against disease.[1]

Other outcomes include the percentage of participants with antibody levels at or above the lower limit of quantification and the percentage with antibody titers at specific cutoffs against MenB strains.[1] These measurements help researchers compare immune responses across age groups and doses.[1]

What the trial data shows

The data provided here shows a vaccine study focused on meningococcal disease prevention, not a rotavirus study.[1] It includes multiple age groups and uses both safety and immune response endpoints to judge the vaccine formulations.[1]

No rotavirus-specific trial details, endpoints, or participant groups were included in the source material for ROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS.[1]

Trial ID Phase Condition studied Status Enrollment
2023-510465-10-00 Phase 2 Meningococcal immunization Authorised 750

FAQ

  • Who is being studied in these clinical trials? The trial data includes healthy infants, toddlers, and children. The main goal is to study vaccine response and safety in these age groups.
  • What are the trials trying to find out? The trials are looking at safety and immunogenicity, which means how well the vaccine helps the body make protective antibodies. They also measure reactions after vaccination.
  • What phase is the trial? The study shown is a Phase 2 trial. Phase 2 studies usually look more closely at safety and how the immune system responds.
  • What condition is being studied? The condition studied is meningococcal immunization. The trial is testing vaccine responses against meningococcal disease in young participants.
  • What results are measured in the trial? The trial measures adverse events, injection site reactions, and immune markers such as antibody titers and seroresponse. These results help show safety and how strong the immune response is.

Ongoing Clinical Trials on ROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS

  • Safety and immunogenicity study of Pentavalent Meningococcal ABCYW vaccine (MenPenta SD and MenPenta fHD) compared to licensed meningococcal vaccines in infants, toddlers and children

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Czechia Denmark Finland Germany Poland Spain

Glossary

  • Adverse event (AE): Any unwanted medical problem that happens during a study. It may or may not be caused by the study vaccine.
  • Serious adverse event (SAE): A medical problem that is severe, such as one that causes hospital care or is life-threatening.
  • Immunogenicity: How well a vaccine makes the immune system respond and produce protection.
  • Antibody titer: A measure of how much antibody is in the blood. Higher levels can mean a stronger immune response.
  • hSBA: Human serum bactericidal assay. This is a lab test used to see whether antibodies can help kill bacteria.
  • Seroresponse: A change in blood antibody levels after vaccination that shows the body has responded.
  • Geometric mean titer (GMT): An average way to report antibody levels in a group. It is often used in vaccine studies.
  • Lower limit of quantification (LLOQ): The lowest level that a lab test can measure reliably.
  • Comparator vaccine: A vaccine used for comparison in a study so researchers can judge the study vaccine.
  • Phase 2: A mid-stage clinical trial that looks at safety and immune response in a larger group than Phase 1.

References