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

NCT06280144 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6080

Last updated 2024-02-28

No results posted yet for this 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.

Conditions

  • Influenza Prevention

Interventions

BIOLOGICAL

Influenza Vaccine, Live, Nasal, Freeze-dried

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

OTHER

Sterile water for inhalation

Sterile water for inhalation

Sponsors & Collaborators

  • Hu Bei province Center for Disease control and prevention

    collaborator UNKNOWN

  • The Inner Mongolia Autonomous Region Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2024-06-30
Completion
2024-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280144 on ClinicalTrials.gov