A Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)

Influenza Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964065
• Other study ID #: F20160728
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2016
• Last updated: September 13, 2017
• Start date: November 2016

Study information

• Verified date: September 2017
• Source: Changchun BCHT Biotechnology Co.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.

Description:

This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years old. The subjects will be randomized in a 1:1 ratio of LAIV to placebo. Each subject will be vaccinated with a single dose of LAIV or Placebo. For evaluation of efficacy, subjects meeting the protocol-defined clinical case definition the 14th day post-vaccination will have a nasal swab collected for testing by RT-PCR or virus culture for evidence of influenza virus infection. All adverse events will be collected 30 minutes, 0-30 days after vaccination and all serious adverse events during the entire trial period. Blood samples will be collected from a part of subjects before vaccination and at the 30th day after immunization. Serum samples will be centrifuged for detection of antibodies to H1N1, H3N2, and influenza B.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9000
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Healthy children and adolescents aged 3-17 years old.

2. Informed consent obtained and signed by subjects or legal guardians prior to screening. Children or adolescents aged 10-17 yrs need sign informed consent by themselves.

3. Willing to participate for the planned duration of the study, including availability for follow-up.

Exclusion Criteria:

1. Any investigational or unregistered product (drug, vaccine or device) was used within 30 days, or planned to be used during the trial.

2. have been vaccinated with any influenza vaccine within 6 months, or plan to be vaccinated during the trail.

3. Immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) were used over a 3-month period.

4. Immunoglobulins and / or any blood products were used within 3 months, or planned to be used before blood collection.

5. History of Guillain-Barré syndrome; History of hypersensitivity to any component of the LAIV, including egg or egg products.

6. Severe allergic reactions after vaccination (including anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis).

7. Acute diseases , infections or febrile diseases (axillary temperature =37.1?) on the day of vaccination.

8. Obvious coagulation dysfunction or History of anticoagulant therapy

9. Aspirin is being used(Salicylates are a potential risk factor for Reye syndrome)

10. Known or suspected immune deficiency diseases or immunosuppressed

11. Heart disease, respiratory diseases (including severe rhinitis, nasal deformities, polyps, etc.), liver disease, kidney disease, mental disorders, chronic infections etc.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Live-Attenuated influenza Vaccine(LAIV)

• Placebo

Locations

Country	Name	City	State
China	Guangdong Provincial Institute of Biological Products and Materia Media	Guangzhou	Guangdong
China	Zhejiang Provincial Center for Disease Control and Prevention	Hangzhou	Zhejiang
China	Hebei Provincial Center for Disease Control and Prevention	Shijiazhuang Shi	Hebei

Sponsors (7)

Lead Sponsor

Collaborator

Changchun BCHT Biotechnology Co.

Baoding Municipal Center for Disease Control and Prevention, Hebei, P.R.China, Beijing Simoonrecord Pharma information Consulting Co, Ltd, Department of Medical Statistics, Fourth Military Medical University, Maoming Municipal Center for Disease Control and Prevention, Guangdong, P.R.China, National Institutes for Food and Drug Control, China, Zhejiang Provincial Center for Disease Control and Prevention, P.R.China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Vaccine-like Strains)		Through 2 weeks to 1 year post vaccination
Secondary	Percentage of Subjects With Symptomatic, Laboratory-confirmed(RT-PCR/ Virus Culture) Influenza Virus Infection(Regardless of Vaccine Match)		Through 2 weeks to 1 year post vaccination
Secondary	Percentage of Subjects with influenza-like illness caused by Influenza Virus Infection(Laboratory-confirmed by RT-PCR/ Virus Culture)		Through 2 weeks to 1 year post vaccination
Secondary	Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine		Through 30 minutes post vaccination
Secondary	Solicited Adverse Events		Through 14 days post vaccination
Secondary	Unsolicited Adverse Events		Through 30 days post vaccination
Secondary	Serious Adverse Events		Through 1 year post vaccination
Secondary	Geometric Mean Titers (GMT) of Hemagglutination Inhibition (HAI) Antibodies to each of the Influenza Strains in the Vaccine Received		30 days post vaccination
Secondary	Percentage of subjects with antibody positive conversion to each of the Influenza Strains in the Vaccine Received.		30 days post vaccination