NCT02964065

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,000

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

November 11, 2016

Last Update Submit

September 13, 2017

Conditions

Influenza

Keywords

Influenza VaccinesLAIV

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • 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

  • Adverse Events Occurring Within 30 Minutes of Administration of Study Vaccine

    Through 30 minutes post vaccination

  • Solicited Adverse Events

    Through 14 days post vaccination

  • Unsolicited Adverse Events

    Through 30 days post vaccination

  • +3 more secondary outcomes

Study Arms (2)

LAIV

EXPERIMENTAL

a single dose of Live-Attenuated influenza Vaccine;Dose: 0.2 ml; Each dose contains not less than 6.9 lg EID50 of type A live attenuated influenza virus reassortants(H1N1 and H3N2), and not less than 6.4 lg EID50 of type B live attenuated influenza virus reassortants.

Biological: Live-Attenuated influenza Vaccine(LAIV)

Placebo

PLACEBO COMPARATOR

a single dose of Placebo. Inactivated placebo will be identical to LAIV in appearance, ingredients and concentrations, attenuated influenza virus free.

Biological: Placebo

Interventions

Live-Attenuated influenza Vaccine(LAIV)BIOLOGICAL
LAIV
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children and adolescents aged 3-17 years old.
  • 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.
  • Willing to participate for the planned duration of the study, including availability for follow-up.

You may not qualify if:

  • Any investigational or unregistered product (drug, vaccine or device) was used within 30 days, or planned to be used during the trial.
  • have been vaccinated with any influenza vaccine within 6 months, or plan to be vaccinated during the trail.
  • Immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) were used over a 3-month period.
  • Immunoglobulins and / or any blood products were used within 3 months, or planned to be used before blood collection.
  • History of Guillain-Barré syndrome; History of hypersensitivity to any component of the LAIV, including egg or egg products.
  • Severe allergic reactions after vaccination (including anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis).
  • Acute diseases , infections or febrile diseases (axillary temperature ≥37.1℃) on the day of vaccination.
  • Obvious coagulation dysfunction or History of anticoagulant therapy
  • Aspirin is being used(Salicylates are a potential risk factor for Reye syndrome)
  • Known or suspected immune deficiency diseases or immunosuppressed
  • Heart disease, respiratory diseases (including severe rhinitis, nasal deformities, polyps, etc.), liver disease, kidney disease, mental disorders, chronic infections etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Guangdong Provincial Institute of Biological Products and Materia Media

Guangzhou, Guangdong, 511430, China

Location

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

Location

Zhejiang Provincial Center for Disease Control and Prevention

Hangzhou, Zhejiang, 310051, China

Location

Related Publications (2)

  • Ai L, Gao Z, Lv H, Zhang J, Xu N, Zhao H, Lu Q, Zhu H, Shi N, Wei W, Liu D, Yu Q. Immunogenicity and safety of live attenuated influenza vaccine in children aged 3-17 years in China. Vaccine. 2025 Feb 6;46:126653. doi: 10.1016/j.vaccine.2024.126653. Epub 2024 Dec 26.

    PMID: 39729925DERIVED

  • Wang S, Zheng Y, Jin X, Gan Z, Shao Y, Zhu C, Hu X, Liang Z, Chen Y, Xing B, Lv H, Xu N. Efficacy and safety of a live attenuated influenza vaccine in Chinese healthy children aged 3-17 years in one study center of a randomized, double-blind, placebo-controlled phase 3 clinical trial, 2016/17 season. Vaccine. 2020 Aug 27;38(38):5979-5986. doi: 10.1016/j.vaccine.2020.07.019. Epub 2020 Jul 31.

    PMID: 32747213DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 15, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)