Phase 1 Study on Safety, Tolerability, and Immunogenicity of Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP in Healthy Adults

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **immunogenicity** of the adjuvanted universal influenza vaccine "fH1/DSP-0546LP" in healthy adults. This is a first-in-human Phase 1 study, which is crucial for determining the initial safety profile and immune response elicited by the vaccine candidate. Understanding these parameters is essential for assessing the potential of the vaccine to provide broad protection against **influenza**, a significant public health concern due to its high morbidity and mortality rates globally.

The clinical trial focuses on **Influenza** and includes a study population comprising both male and female participants. The age range of the participants is categorized as adults, specifically between 18 to 64 years. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is a **Phase 1** study designed to evaluate the safety, tolerability, and immunogenicity of an adjuvanted universal influenza vaccine in healthy adults. The trial employs a **randomized**, **double-blind**, and **controlled** design to ensure the reliability and validity of the results. The estimated duration of the trial spans from May 15, 2024, to June 30, 2026, allowing for comprehensive data collection and analysis. Participants will be involved in a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Subsequent follow-up visits will be scheduled to monitor participants' responses to the vaccine and to collect necessary data. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the primary and secondary endpoints. The expected length of participant involvement will be determined by the study protocol, with specific conditions outlined for early termination, such as adverse events or withdrawal of consent. The trial is structured to ensure participant safety and the integrity of the data collected throughout the study period.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The trial documentation does not include any information on the **pharmaceutical form**, **dosage**, or **administration route** of the investigational product, nor does it specify any **comparator treatments** or **placebo** used in the study. Consequently, the description remains limited to the acknowledgment of missing data in the source provided.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to commence recruitment on May 15, 2024, with an estimated completion date of June 30, 2026. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize a combination of clinical observations and laboratory tests to gather initial efficacy data. The methods and schedule for measuring, collecting, and analyzing efficacy parameters are not specified in the available data. The trial will adhere to standard protocols for data collection and analysis, ensuring that any efficacy-related findings are scientifically valid and reliable.