Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine

Last updated: February 19, 2024
Sponsor: Changchun BCHT Biotechnology Co.
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Sterile water for inhalation

Influenza Vaccine, Live, Nasal, Freeze-dried

Clinical Study ID

NCT06280144
PF20230428
  • Ages 3-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.

To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Subjects who meet the contraindications and precautions specified in the vaccineinstructions:
  2. Those known to be allergic to any ingredients of this product, including eggs,excipients, gentamycin sulfate;
  3. Patients with acute disease, severe chronic disease, the acute onset of chronicdisease and fever;
  4. Women in pregnancy;
  5. Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs;
  6. Immunodeficient, immunocompromised, or under immunosuppressive therapy;
  7. 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).
  8. Have received other clinical study drugs or were participating in other clinicaltrials within 1 month before entering the cohort.
  9. Have received any influenza vaccine during this natural year before entering the study
  10. Those who have been diagnosed with influenza in this natural year before entering thestudy.
  11. Any condition that the investigator judged to affect the trial.

Study Design

Total Participants: 6080
Treatment Group(s): 2
Primary Treatment: Sterile water for inhalation
Phase: 4
Study Start date:
September 22, 2023
Estimated Completion Date:
October 30, 2024

Study Description

Main end point:

Primary influenza protective effect endpoint Protective effect of 14 days on laboratory-confirmed influenza cases. Protective effect of 14 days after receiving lyophilized nasal spray live attenuated influenza vaccine on laboratory-confirmed serotype influenza cases.

Secondary endpoints:

Secondary point of secondary endpoint Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 0 days later on laboratory-confirmed influenza cases.

Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on clinically diagnosed influenza cases.

Protective effect of live attenuated influenza-like vaccine 14 days against influenza-like cases.

safety Incidence of adverse events and serious adverse events within 0-30 days after immunization.

Study on detoxification Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).

Exploration endpoint:

14 days after the freeze-dried nose vaccine, the vaccine was protective for the detection of COVID-19 cases.

Connect with a study center

  • Chi Feng, Inner Mongolia Autonomous Region 024000
    China

    Active - Recruiting

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