NCT04825340

To Explore a Bridging Index for the Effectiveness of the Clinical Trial

To Explore a Bridging Index for the Effectiveness of the Clinical Trial With Nasal Spray Lyophilized Live Attenuated Influenza Vaccine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 3 Years – 59 Years
• Healthy volunteers: Accepted

Summary

To explore a bridging index for the effectiveness of the clinical trial with Nasal Spray Lyophilized Live Attenuated Influenza Vaccine

Detailed description

With a randomized, blind, parallel placebo-controlled design, to screen the susceptible individuals aged 3\~59 years old whose titers of either of Hi antibody level of H1N1, H3N2 or B are not higher than 1:10 prior immunization , in which all persons are to be assigned into the two subgroups (aged 3\~17 and 18\~59 years old) with radio of 1:1, individually. All persons of each age subgroups are to be randomly assigned into the two groups (vaccine or placebo group) with th radio of 2:1 via intranasal injection of one dose of the study vaccine or placebo. The blood samples are to be collected prior immunisation and on the 21st day post immunisation, individually, the nasopharyngeal swab samples are also to be done prior immunisation and on the 10th day and 21st day post immunisation, individually, and the levels of serum HI antibody and mucous sIgA antibody are to be compared between the two groups, respectively.

Conditions

• Randomized

Interventions

Type	Name	Description
BIOLOGICAL	Nasal Spray Lyophilized Live Attenuated Influenza Vaccine	0.2 ml/vial, 0.2ml/dose/per person

Timeline

• Start date: 2021-04-16
• Primary completion: 2022-03-25
• Completion: 2022-03-25
• First posted: 2021-04-01
• Last updated: 2021-04-13