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

NCT06280144 | Unknown Phase 4

• 1 other identifier: PF20230428
• Study Type: interventional
• Target: 6,080
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza Prevention

Keywords

Protection effect

Outcome Measures

Primary Outcomes (2)

• Primary influenza protective effect endpoint

  Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days on the incidence of laboratory-confirmed influenza cases

  7 months

• Primary influenza protective effect endpoint

  Protective effect of 14-day live attenuated influenza vaccine on the incidence of laboratory-confirmed cases of serotype influenza.

  7 months

Secondary Outcomes (5)

• Secondary protective efficacy endpoint

  Seven months

• Secondary protective efficacy endpoint

  Seven months

• Secondary protective efficacy endpoint

  Seven months

• Safety

  One month

• Study on detoxification

  15 days

Other Outcomes (1)

• Protective effect of COVID-19 cases.

  Seven months

Study Arms (2)

Experimental group

EXPERIMENTAL

Influenza Vaccine, Live, Nasal, Freeze-dried

Biological: Influenza Vaccine, Live, Nasal, Freeze-dried

Placebo group

PLACEBO COMPARATOR

Sterile water for inhalation

Other: Sterile water for inhalation

Interventions

Influenza Vaccine, Live, Nasal, Freeze-dried BIOLOGICAL

The titer of live attenuated influenza virus containing A (H1N1) and A (H3N2) should not be less than 6.9 lg EID50, and the titer of live attenuated influenza B virus should not be less than 6.4 lg EID50

Experimental group

Sterile water for inhalation OTHER

Sterile water for inhalation

Placebo group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• Hu Bei province Center for Disease control and prevention: collaborator
• The Inner Mongolia Autonomous Region Center for Disease Control and Prevention: collaborator

Study Sites (1)

Unknown Facility

Chifeng, Inner Mongolia, 024000, China

RECRUITING

MeSH Terms

Interventions

Influenza Vaccines; Freeze Drying; Inhalation

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Cryopreservation; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Xibao Huang

CONTACT

027-87652133; hxb6407@163.com

Xiaoling Tian

CONTACT

13848710296; txlingok@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: February 28, 2024
• Study Start: September 22, 2023
• Primary Completion: June 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-12

Locations

CN (1)