Not yet recruiting NCT07133802
Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo Group, Test Group.
- Who it may be relevant to
- Registry conditions: Prevention of Influenza. Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine in Adults Aged 18-59 Years
Overview
A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination
Interventions
- Biological Placebo Group
Each human dose: 0.2 mL - Biological Test Group
Each human dose is 0.2 mL
Primary outcome measures
- Protective Efficacy [Time frame: at 14 days post-vaccination]
Secondary outcome measures (7)
- Protective Efficacy [Time frame: at 14 days post-vaccination]
- Protective Efficacy [Time frame: Throughout the entire study period]
- Protective Efficacy [Time frame: Throughout the entire study period]
- Safety [Time frame: 14 days post-vaccination]
- Safety [Time frame: 30 days post-vaccination]
- Safety [Time frame: During the study period]
- Safety [Time frame: Day 15 post-vaccination]
Eligibility criteria
Inclusion criteria
- Healthy participants aged 18-59 years
- Capable of providing informed consent in person
- Willing and able to comply with all clinical trial requirements
Exclusion criteria
- Axillary temperature >37.0°C on enrollment day \*
- Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial
- History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months
- Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months
- Acute phase of any infectious disease/chronic illness within 3 days, or recent use (≤3 days) of antipyretics/analgesics/antihistamines \*
- History of severe allergies requiring medical intervention (e.g., anaphylaxis, angioedema, Arthus reaction) or hypersensitivity to vaccine components (egg proteins, gentamicin sulfate, etc.)
- Known malignancies, autoimmune diseases (e.g., SLE, rheumatoid arthritis), or immunodeficiency (HIV, organ transplantation, etc.)
- Asplenia, functional asplenia, or any splenectomy history
- Use of immunosuppressants/immunomodulators (e.g., systemic corticosteroids >14 days) within 6 months or planned use during study
- Congenital anomalies affecting organ function, uncontrolled hypertension (≥140/90 mmHg despite treatment), or severe hepatic/renal diseases (e.g., diabetes-complicated)
- Active asthma or clinical remission for <12 months
- History or family history of neurological/psychiatric disorders (e.g., epilepsy, Guillain-Barré syndrome)
- Salicylate use (e.g., aspirin) within 30 days or planned use within 6 weeks post-vaccination
- Nasal abnormalities potentially affecting vaccine administration (e.g., active allergic rhinitis with medication, ongoing nasal sprays)
- Blood products/immunoglobulin administration within 3 months or planned use during trial
- Live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment \*
- Participation in other clinical trials within 1 month or concurrent involvement in interventional studies
- Any condition deemed by investigators to compromise trial integrity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07133802 · B1506-20250113