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

NCT04825340 | Unknown

• 1 other identifier: F202110111
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Randomized

Keywords

Influenza Vaccine Nasal Spray

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The ratios and 95% CI of the GMTs of serum HI antibodies of all H1N1, H3N2 and B

  0-21days

Study Arms (2)

Study vaccine

EXPERIMENTAL

Nasal Spray Lyophilized Live Attenuated Influenza Vaccine

Biological: Nasal Spray Lyophilized Live Attenuated Influenza Vaccine

Placebo

PLACEBO COMPARATOR

commercial normal saline

Biological: Nasal Spray Lyophilized Live Attenuated Influenza Vaccine

Interventions

Nasal Spray Lyophilized Live Attenuated Influenza Vaccine BIOLOGICAL

0.2 ml/vial, 0.2ml/dose/per person

Placebo; Study vaccine

Eligibility Criteria

• Age: 3 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Known allergy individual to any ingredient of this product, including egg protein, subsidiary material and/or gentamycin sulfate;
• patients with acute disease, severe chronic disease, acute attack of chronic disease and/or fever (axillary temperature ≥ 37.3℃ on the day of immunisation);
• pregnancy (enquire);
• patients with Leigh syndrome treated with aspirin or aspirin containing drugs;
• patients with immunodeficiency or receiving immunosuppressive therapy;
• patients with uncontrolled epilepsy and other progressive nervous system diseases, with a history of Guillain Barre syndrome;
• patients with rhinitis or other nasal abnormalities judged by clinicians that may affect vaccination or sample collection;
• 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);
• taking anti influenza drugs in the past 48 hours;
• any situation that the researchers believe may affect the study.

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: April 16, 2021
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-03