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534

Clinical trials are investigating 534 in infants and toddlers to see if it can help prevent respiratory syncytial virus, also called RSV. The main goals are to check efficacy, immunogenicity, and safety in young children. These studies focus on prevention of RSV lower respiratory tract disease.

Table of Contents

Clinical trial overview

The available trial for 534 is a Phase 3 study in infants and toddlers that is marked as Authorised.[1] It is an interventional study, which means researchers give a study treatment and then measure the results.[1]

This trial is studying a respiratory syncytial virus, or RSV, vaccine and is focused on virus diseases.[1] The brief summary says the goal is to show clinical efficacy for prevention of RT PCR confirmed RSV lower respiratory tract disease after 2 doses over RSV Season 1.[1]

Study design and treatment groups

The trial includes 2 study interventions: a live attenuated RSV ∆NS2/∆1313/I1314L vaccine given by nasal use, and a matched control.[1] A matched control is a comparison group designed to look similar to the vaccine group so researchers can better judge the effect of the study treatment.

The planned enrollment is 6,300 participants, which means the study is designed to include a large number of young children.[1] A large study helps researchers collect enough information to judge both benefit and safety more reliably.

Who can participate

The source data says the target population is infants and toddlers.[1] No more detailed entry rules are given in the source data, so the exact age range, health requirements, and other eligibility rules are not listed here.

Because the study is focused on very young children, it is aimed at a group that can be at higher risk for RSV illness.[1] The source does not describe whether children must already have had RSV before joining.

What the trial measures

The main endpoint is the occurrence of lower respiratory tract disease during RSV Season 1, linked to any RT PCR confirmed RSV strain and measured more than 21 days after dose 2.[1] An endpoint is the main result a trial is designed to measure.

RT PCR is a lab test that looks for virus genetic material, so this endpoint checks for RSV cases that are confirmed by testing rather than symptoms alone.[1] The trial also aims to assess efficacy, immunogenicity, and safety.[1]

Efficacy means how well the vaccine works, immunogenicity means how strongly the immune system responds, and safety means how well the treatment is tolerated in the study.[1]

What the results will help answer

This trial is designed to answer whether 534 can help prevent RSV lower respiratory tract disease in young children after a 2-dose schedule.[1] It will also help researchers understand whether the vaccine produces an immune response and whether it can be studied safely in a large pediatric group.[1]

Because the study is Phase 3, the results may be important for deciding how well the RSV vaccine works in real-world use if the findings are positive.[1]

Trial ID Phase Condition studied Status Enrollment
2023-505762-29-00 Phase 3 Virus diseases / RSV lower respiratory tract disease prevention Authorised 6300

FAQ

  • What are the clinical trials of 534 studying? They are studying whether 534 can help prevent RSV lower respiratory tract disease in infants and toddlers. The trials also look at safety and whether the body makes an immune response.
  • Who can take part in these trials? The trial is designed for infants and toddlers. The source data does not give more details about exact age limits or other entry rules.
  • What phase is the 534 trial? The trial is in Phase 3. This means it is a late-stage study that tests how well the vaccine works and continues to monitor safety in a large group.
  • What condition is being studied? The condition is RSV, which is a virus disease. The study focuses on RSV lower respiratory tract disease, a lung and breathing problem caused by RSV.
  • What outcome is the trial measuring? The main outcome is whether children develop RSV lower respiratory tract disease after the second dose. The study checks cases confirmed by an RT PCR test, which is a lab test that detects virus genetic material.

Ongoing Clinical Trials on 534

  • Study on the Effectiveness and Safety of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Finland Germany Spain

Glossary

  • Respiratory syncytial virus (RSV): A common virus that can cause breathing illness, especially in young children.
  • Infants and toddlers: Very young children, including babies and small children.
  • Phase 3: A late stage of clinical research where a treatment is tested in a large group to see how well it works and to keep checking safety.
  • Efficacy: How well a treatment works in a trial.
  • Immunogenicity: How strongly the body’s immune system responds to a vaccine.
  • Safety: Information about unwanted effects and whether the treatment is tolerated in the study.
  • Lower respiratory tract disease (LRTD): Illness in the lower airways and lungs, such as the chest area below the throat.
  • RT PCR: A laboratory test that looks for virus genetic material to confirm an infection.
  • Authorised: Approved to begin or continue as a clinical study.
  • Interventional study: A study where participants receive a treatment or vaccine so researchers can measure the results.
  • Enrollment: The number of participants planned for the trial.

References

  1. https://clinicaltrials.gov/study/2023-505762-29-00