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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Randomized
• Intervention / Treatment: Biological: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 59 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. healthy volunteer aged 3~59 years old；
2. no vaccination with any influenza vaccine within the past year；
3. no catching any influenza or flu like symptoms （axillary temperature ≥ 38℃， accompanied by cough or sore throat ）；
4. influenza susceptible individual（any serum Hi antibody level of H1N1, H3N2 and B≦1:10）；
5. with informed consent obtained from the volunteer and / or guardian；
6. willing of volunteers and / or guardians to comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

1. Known allergy individual to any ingredient of this product, including egg protein, subsidiary material and/or gentamycin sulfate;
2. patients with acute disease, severe chronic disease, acute attack of chronic disease and/or fever (axillary temperature ≥ 37.3℃ on the day of immunisation);
3. pregnancy (enquire);
4. patients with Leigh syndrome treated with aspirin or aspirin containing drugs;
5. patients with immunodeficiency or receiving immunosuppressive therapy;
6. patients with uncontrolled epilepsy and other progressive nervous system diseases, with a history of Guillain Barre syndrome;
7. patients with rhinitis or other nasal abnormalities judged by clinicians that may affect vaccination or sample collection;
8. accept any immunoglobulin and / or any blood products within 3 months, or plan to use them during the study (until post immunization blood sample collection);
9. .taking anti influenza drugs in the past 48 hours;
10. .any situation that the researchers believe may affect the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study vaccine; Nasal Spray Lyophilized Live Attenuated Influenza Vaccine	Biological: Nasal Spray Lyophilized Live Attenuated Influenza Vaccine; 0.2 ml/vial, 0.2ml/dose/per person
Placebo Comparator: Placebo; commercial normal saline	Biological: Nasal Spray Lyophilized Live Attenuated Influenza Vaccine; 0.2 ml/vial, 0.2ml/dose/per person

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The GMTs of serum HI antibodies of all H1N1, H3N2 and B	The GMTs of serum HI antibodies of all H1N1, H3N2 and B on the 21st day post immunization;	0-21 days
GMTs of HI sIgA antibodies of all H1N1, H3N2 and B	The mucous GMTs of HI sIgA antibodies of all H1N1, H3N2 and B on the 10th and 21st day post immunization;	10-21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B	The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B on the 21st day post immunization;	0-21days

Collaborators and Investigators

• Sponsor: Changchun BCHT Biotechnology Co.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 16, 2021
• Primary Completion (Anticipated): March 25, 2022
• Study Completion (Anticipated): March 25, 2022

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: March 28, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Influenza Vaccine Nasal Spray
• Other Study ID Numbers: F202110111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No