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

NCT02964065 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9000

Last updated 2017-09-14

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Live-Attenuated influenza Vaccine(LAIV)

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • Simoon Record Pharma Information Consulting Co., Ltd.

    collaborator INDUSTRY

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • Baoding Municipal Center for Disease Control and Prevention, Hebei, P.R.China

    collaborator UNKNOWN

  • Zhejiang Provincial Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Maoming Municipal Center for Disease Control and Prevention, Guangdong, P.R.China

    collaborator UNKNOWN

  • Department of Medical Statistics, Fourth Military Medical University

    collaborator UNKNOWN

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964065 on ClinicalTrials.gov