Evaluating a nasal spray vaccine for influenza prevention

Multi-center, Randomized, Double-blind, Placebo-controlled Trial of a Live Attenuated Influenza Vaccine in People Aged 3-17

This study is testing a nasal spray vaccine for flu to see if it can safely prevent flu and possibly help protect against COVID-19 as well.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6080 (estimated)
• Ages: 3 Years to 17 Years
• Sex: All
• Sponsor: Changchun BCHT Biotechnology Co. (Industry-sponsored)
• Locations: 1 site (Chi Feng, Inner Mongolia Autonomous Region)
• Trial ID: NCT06280144 on ClinicalTrials.gov

What this trial studies

This study assesses the protective effect of a lyophilized nasal spray live attenuated influenza vaccine 14 days post-vaccination. It aims to evaluate both the safety and effectiveness of the vaccine in preventing laboratory-confirmed influenza cases. Additionally, the study will explore the vaccine's potential protective effect against COVID-19. Participants will be monitored for adverse events and the vaccine's genetic stability over time.

Who should consider this trial

Good fit: Ideal candidates for this study are local residents aged between 3 and 17 who can provide informed consent and have a normal body temperature.

Not a fit: Patients with known allergies to vaccine components, severe chronic diseases, or those who are immunocompromised may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide an effective means of preventing influenza and potentially COVID-19 in children and adolescents.

How similar studies have performed: Other studies have shown success with live attenuated influenza vaccines, indicating a promising approach for this novel formulation.

Eligibility criteria

Inclusion Criteria:

1. Local residents aged between 3 and 17;
2. People who signed the informed consent form and could actively cooperate with the study；
3. Axillary body temperature of 37.0℃.

Exclusion Criteria:

1. Subjects who meet the contraindications and precautions specified in the vaccine instructions:

   1. Those known to be allergic to any ingredients of this product, including eggs, excipients, gentamycin sulfate;
   2. Patients with acute disease, severe chronic disease, the acute onset of chronic disease and fever;
   3. Women in pregnancy;
   4. Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs;
   5. Immunodeficient, immunocompromised, or under immunosuppressive therapy;
   6. Patients with uncontrolled epilepsy and other progressive neurological diseases, patients with a history of Guillain-Barre syndrome; And g. patients with rhinitis (with a clear diagnosis and in the onset of rhinitis).
2. Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort.
3. Have received any influenza vaccine during this natural year before entering the study
4. Those who have been diagnosed with influenza in this natural year before entering the study.
5. Any condition that the investigator judged to affect the trial.

Where this trial is running

Chi Feng, Inner Mongolia Autonomous Region

• Chi Feng, Inner Mongolia Autonomous Region, China (Recruiting)

Study contacts

• Study coordinator: Xibao Huang

Conditions Influenza Prevention; Protection effect